Amgen deploys patients to defend troubled Tavneos in FDA hearing request
Amgen deploys patients to defend troubled Tavneos in FDA hearing request.
Biopharm & Life Sciences Intelligence
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Latest Intelligence Updates
Arrowhead hits 'best-case scenario' with latest results for fat-lowering drug
Arrowhead hits 'best-case scenario' with latest results for fat-lowering drug.
Asymchem's Dunhua 2 Carbapenem Manufacturing Site Successfully Completes its First FDA Inspection for Continuous Manufacturing of an API
Asymchem's Dunhua 2 Carbapenem Manufacturing Site Successfully Completes its First FDA Inspection for Continuous Manufacturing of an API.
Biogen R&D vet gets in Formation—Chutes & Ladders
Biogen R&D vet gets in Formation—Chutes & Ladders.
Biogen’s Alzheimer’s data spur excitement, confusion about tau-targeting drugs
Biogen’s Alzheimer’s data spur excitement, confusion about tau-targeting drugs.
CHMP recommends Minoryx’s ALD drug, rejects Zevra’s Meplyffa
CHMP recommends Minoryx’s ALD drug, rejects Zevra’s Meplyffa.
FDA adcomm votes in favor of lifting restrictions on popular wellness peptide BPC-157
FDA adcomm votes in favor of lifting restrictions on popular wellness peptide BPC-157.
FDA to end pilot aimed at preventing production issues
FDA to end pilot aimed at preventing production issues.
Gene editor Scribe Therapeutics starts second-half IPO spree with $129M listing
Gene editor Scribe Therapeutics starts second-half IPO spree with $129M listing.
Generic tariffs, Samsung Bio, HK IPO—Fierce Pharma Asia
Generic tariffs, Samsung Bio, HK IPO—Fierce Pharma Asia.
GSK’s first lung cancer approval, a new IPO path and more
GSK’s first lung cancer approval, a new IPO path and more.
I may be one of the last middle-class medical students who could afford to become a doctor
I may be one of the last middle-class medical students who could afford to become a doctor.
Ipsen's liver disease drug Bylvay fails biliary atresia trial
Ipsen's liver disease drug Bylvay fails biliary atresia trial.
Merck prepares expanded access to monthly PrEP pill early
Merck prepares expanded access to monthly PrEP pill early.
Michael Ehlers joins Formation Bio to lead R&D; Black Diamond co-founder dies at 67
Michael Ehlers joins Formation Bio to lead R&D; Black Diamond co-founder dies at 67.
Novo asks court to block Lilly ads; Merck strikes HIV PrEP deal
Novo asks court to block Lilly ads; Merck strikes HIV PrEP deal.
Roche receives FDA clearance for the cobas® BV/CV assay, enabling fast and highly accurate vaginitis diagnosis
Roche receives FDA clearance for the cobas® BV/CV assay, enabling fast and highly accurate vaginitis diagnosis.
Sanofi nixes Kymab-originated OX40L antibody in eczema
Sanofi nixes Kymab-originated OX40L antibody in eczema.
Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped
Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped.
Sanofi won't seek approval for eczema drug from Kymab buyout
Sanofi won't seek approval for eczema drug from Kymab buyout.
Sartorius reduces revenue by €26M to refund Trump tariffs to customers
Sartorius reduces revenue by €26M to refund Trump tariffs to customers.
Scribe records upsized $129M IPO to fund genetic med trials
Scribe records upsized $129M IPO to fund genetic med trials.
Senate advances MAHA-friendly bill for food warning labels and junk food ad bans
Senate advances MAHA-friendly bill for food warning labels and junk food ad bans.
Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study.
The U.S. pharmaceutical supply chain problem is not about China
The U.S. pharmaceutical supply chain problem is not about China.
Trump threatens tariffs on imported generic drugs
Trump threatens tariffs on imported generic drugs.
Australia's Clinuvel to shed up to 20% of workforce in US move
Australian biopharma Clinuvel announces plans to shed up to 20% of its workforce as part of a strategic U.S. market expansion.
BeOne commits $300M to US manufacturing expansion, creating 120 new jobs
BeOne commits $300 million to U.S. manufacturing expansion, creating 120 new jobs in a domestic production build-out.
BeOne joins reshoring parade with $300M US production expansion
BeOne joins reshoring parade with $300M US production expansion.
Biogen bets newly acquired Apellis can paper over Leqembi's disappointing sales into 2027
Biogen bets newly acquired Apellis can paper over Leqembi's disappointing sales into 2027.
FDA Clears Momentis Surgical's Anovo® System for Multiport Surgery, Making It the First Robotic Platform to Support Three Surgical Approaches
FDA Clears Momentis Surgical's Anovo® System for Multiport Surgery, Making It the First Robotic Platform to Support Three Surgical Approaches.
FDA Clears Momentis Surgical's Anovo® System for Multiport Surgery, Making It the First and Only FDA-Cleared Surgical Robot for Transvaginal Procedures
FDA clears Momentis Surgical's Anovo system for multiport surgery, expanding indications for the robotic-assisted platform.
FDA panel favors peptides on 1st day of compounding adcomm
FDA panel favors peptides on 1st day of compounding adcomm.
Filing of bipartisan Senate bill boosts momentum for office of men’s health
Filing of bipartisan Senate bill boosts momentum for office of men’s health.
First Published Clinical Study Demonstrates Feasibility of Fluorescence Imaging in Orthopaedic Surgery
First peer-reviewed clinical study demonstrates the feasibility of fluorescence imaging-guided surgery in a published trial.
How the FDA is unwinding the Makary era, and making way for a new commissioner
How the FDA is unwinding the Makary era, and making way for a new commissioner.
J&J bispecific combo delivers 89% PFS benefit in myeloma
J&J bispecific combo delivers 89% PFS benefit in myeloma.
J&J bispecific combo delivers 89% PFS benefit in myeloma
Johnson & Johnson's bispecific antibody combination delivers an 89% progression-free survival benefit in a multiple myeloma trial.
Lilly preps FDA run for 'triple-G' weight loss drug with Phase 3 data
Eli Lilly prepares an FDA submission for its triple-G weight loss drug following positive Phase 3 data.
Lilly triple-G drug hits 22% weight loss, cardio impact unclear
Eli Lilly's triple-agonist (triple-G) obesity drug hits 22% weight loss in Phase 3, with cardiovascular impact still unclear.
Lundbeck receives FDA Fast Track designation for Lu AH69593, an investigational orexin 2 receptor agonist for narcolepsy
Lundbeck receives FDA Fast Track designation for Lu AH69593, an investigational orexin 2 receptor agonist for narcolepsy.
Lundbeck receives FDA Fast Track designation for Lu AH69593, an investigational therapy for a CNS indication
Lundbeck receives FDA Fast Track designation for Lu AH69593, an investigational therapy for an undisclosed central nervous system indication.
Roche defends 6B franc Vabysmo peak target despite another miss
Roche defends 6B franc Vabysmo peak target despite another miss.
Roche drops lupus TCE, retains autoimmune cell therapy interest
Roche drops its lupus T-cell engager program but retains broader autoimmune cell therapy ambitions following pipeline review.
Roche's late stage pipeline 'so full,' CEO Schinecker not feeling pressure to add M&A
Roche CEO Schinecker says the company's late-stage pipeline is "so full" he's not feeling pressure to pursue major M&A.
Roche says it is thoughtful on token use for AI, shelves a drug from Carmot buy
Roche says it is thoughtful on token use for AI, shelves a drug from Carmot buy.
Scancell heads to Nasdaq via reverse merger with Neuphoria
Scancell heads to Nasdaq via a reverse merger with Neuphoria, providing a public listing for the UK immuno-oncology biotech.
Scancell heads to Nasdaq via reverse merger with Neuphoria
Scancell heads to Nasdaq via reverse merger with Neuphoria.
Senate health panel delays vote on CDC nominee
Senate health panel delays vote on CDC nominee.
SimBioSys and Ferrum Health Partner to Expand Access to AI-Powered Surgical Planning Through Ferrum's AI Governance Suite
SimBioSys and Ferrum Health Partner to Expand Access to AI-Powered Surgical Planning Through Ferrum's AI Governance Suite.
SimBioSys and Ferrum Health Partner to Expand Access to AI-Powered Surgical Planning
SimBioSys and Ferrum Health partner to expand access to AI-powered surgical planning tools across U.S. hospitals.
U.S. health officials are investigating a new outbreak of a diarrhea-causing parasite
U.S. health officials are investigating a new outbreak of a diarrhea-causing parasite.
VELMENI Receives FDA 510(k) Clearance for AI-Powered 3D CBCT Dental Imaging Software
VELMENI Receives FDA 510(k) Clearance for AI-Powered 3D CBCT Dental Imaging Software.
Venus Medtech Announces Completion of Patient Enrollment in Pivotal China Trial for Venus-PowerX, the World's First Fully Recoverable Self-Expanding Dry-Valve TAVR System
Venus Medtech Announces Completion of Patient Enrollment in Pivotal China Trial for Venus-PowerX, the World's First Fully Recoverable Self-Expanding Dry-Valve TAVR System.
Venus Medtech Announces Completion of Patient Enrollment in Pivotal China Trial for Its Self-Expanding Transcatheter Pulmonary Valve
Venus Medtech announces completion of patient enrollment in a pivotal China trial for its transcatheter pulmonary valve technology.
6 companies hiring in Cambridge now
6 companies hiring in Cambridge now.
Agios Pharma Drops Sickle Cell Disease Drug After Phase 2 Data Disappoint
Agios Pharmaceuticals said tebapivat fell short of expectations in a Phase 2 test in sickle cell disease.
Agios scraps sickle cell drug
Agios scrapped its sickle cell drug tebapivat after disappointing Phase 2 data.
AI data becomes sticking point in biopharma dealmaking
As drug hunting gets more complex, where and how data is generated in partnerships between Big Pharmas and AI biotechs is becoming a headache for dealmakers.
Arrowhead data set up Redemplo for hypertriglyceridemia nod
Arrowhead data sets up Redemplo as a competitive answer to Ionis in hypertriglyceridemia, ahead of a likely FDA submission.
Arrowhead puts pressure on Ionis with positive data for triglyceride lowering drug
With Phase 3 data showing what analysts called a 'potentially best-in-class profile,' Arrowhead Pharmaceuticals plans to submit for FDA approval of plozasiran by the end of the year—hoping to follow to market Ionis Pharmaceuticals' Tryngolza, which got the regulator's nod in severe hypertriglyceridemia last month.
Arrowhead’s gene silencer competitive with Ionis’ in triglyceride disease
Arrowhead’s gene silencer competitive with Ionis’ in triglyceride disease.
Ascletis Announces Oral Discussion of ASC36_35 FDC Preclinical Data Demonstrating Superior Weight Loss to Eloralintide/Tirzepatide Combination at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting
Ascletis Announces Oral Discussion of ASC36_35 FDC Preclinical Data Demonstrating Superior Weight Loss to Eloralintide/Tirzepatide Combination at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting.
You Can Now Bet on Clinical Trials Like Playoff Games, But Health Execs Say It Crosses a Line
Prediction market Kalshi launched betting markets tied to clinical trial results and FDA approvals.
The biotech recovery gathers speed in Q2
Biopharma dealmaking is gathering speed in Q2 2026 as the recovery continues.
Biopharma layoffs must double in H2 for 2026 to match 2025 cuts
Biopharma layoffs must double in the second half of 2026 to match 2025's full-year job-cut total.
Biotech experts want FDA drug reviews based on science, not politics
Biotech experts are pushing for FDA drug reviews based on science, not politics.
Celldex scraps antibody in itchy skin nodules after Phase 2 flop
Celldex scrapped its antibody for prurigo nodularis after a Phase 2 flop.
Co-Diagnostics Joint Venture CoSara Initiates Clinical Studies in India for Tuberculosis Test on PCR Platform
Co-Diagnostics joint venture CoSara initiated clinical studies in India for a tuberculosis test on its PCR platform.
Congo's Ebola outbreak has killed nearly 1,000 people
Congo's Ebola outbreak has killed nearly 1,000 people as the disease continues to spread.
Crystalys gets $130M to take Sobi-rivaling gout drug to market
Crystalys raised $130M to advance its Sobi-rivaling gout drug through Phase 3 testing.
Crystalys nets $130M more to push gout drug through late-stage tests
Crystalys raised $130M to push its gout drug dotinurad through late-stage testing.
Crystalys mines $130M series B to push gout drug through phase 3
Crystalys raised a $130M series B to push its gout drug through phase 3 testing.
Dimension restocks with $800M to capitalize on AI's 'rapid ascent'
Dimension raised $800M for its third fund to capitalize on AI's 'rapid ascent' in biotech.
FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
FDA announces the first participant selected for the TEMPO for Digital Health Devices pilot program.
FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout
FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout.
FDA plans to name permanent CBER, CDER heads with new commissioner nomination
FDA plans to name permanent CBER, CDER heads with new commissioner nomination.
FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
FDA is taking further steps to remove outdated authorizations for color additives in food.
Former cancer chief Pazdur says FDA has 'golden opportunity' to kill CDER and restructure
Former cancer chief Pazdur says FDA has 'golden opportunity' to kill CDER and restructure.
Gilead, MSD share data on once-weekly oral HIV treatment
Gilead and MSD shared data on a once-weekly oral HIV treatment that achieved high rates of viral suppression in Phase 3.
GSK's $10.6B Nuvalent bet pays off early as FDA approves lung cancer drug
GSK's $10.6 billion Nuvalent bet pays off early as the FDA approves its lung cancer drug.
House passes bill directing FDA to update animal testing rules
U.S. House passes a bill directing the FDA to update its rules on animal testing in preclinical drug development.
Indian generic drugmaker gets FDA warning over clinical study consent
Indian generic drugmaker gets FDA warning over clinical study consent.
Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer
Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer.
Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive NSCLC
FDA approves Jideytro (zidesamtinib) in the U.S. for previously treated ROS1-positive non-small cell lung cancer.
Kaken details the data behind its PI3K inhibitor filing
Kaken has revealed the data that supported its recent marketing application for serabelisib as a treatment for vascular malformations in Japan.
Lakewood-Amedex Biotherapeutics Highlights Nu-3 Resistance Data
Lakewood-Amedex Biotherapeutics highlighted Nu-3 resistance data in response to a national action plan on combating antibiotic-resistant bacteria.
Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates.
As Maui recovers from devastating fires, a study offers vision for new rural health model
Research into disease risk from wildfires evolves into 'science as service'.
Mentari adds $200M to migraine mission; Royalty's latest ATTR-CM deal
Mentari raised $200M for its migraine program while Royalty Pharma announced a new ATTR-CM deal.
New study supports testing of Merck's Ebola vaccine in DRC outbreak
New study supports expanded testing of Merck's Ebola vaccine in response to the ongoing DRC outbreak.
NIH joins Trump's $5B AI mission with biomedical research push
NIH joins the White House's $5B artificial intelligence "Genesis Mission" with a biomedical research push and expanded AI compute.
Novo sues Lilly, alleging 'misleading' advertising of obesity drugs
Novo Nordisk is suing Eli Lilly, alleging 'misleading' advertising of obesity drugs.
Nuvalent deal delivers GSK's first-ever lung cancer approval
GSK's $10.6B Nuvalent deal delivers its first-ever lung cancer FDA approval with Jideytro (zidesamtinib) for ROS1-positive NSCLC.
Precision Neuro breaks new ground in BCI technology
Precision Neuroscience has shown that people can control electronic devices with thought alone, without electrodes implanted in the brain.
Q2 earnings underway, FDA's CRL kerfuffle, IPOs full speed ahead in H2
Q2 earnings underway, FDA's CRL kerfuffle, and IPOs running at full speed into the second half.
Q&A: Lilly returns to neuropsych and looks ahead to Alzheimer's prevention
Eli Lilly returns to neuropsychiatry and looks ahead to Alzheimer's prevention efforts.
Thiel-backed CEO eyes $50M fundraise after bagging China drug
Ashlins Pharma has licensed a Chinese formulation of a well-known medicine and set its sights on a $50 million fundraise.
Repligen’s $1.5B buy for BioLife; BeOne’s $300M US expansion
Repligen’s $1.5B buy for BioLife; BeOne’s $300M US expansion.
Repligen strikes $1.5B BioLife buyout to bag cell therapy product pharmas rely on
Repligen is buying BioLife Solutions in a $1.5 billion deal to expand its cell therapy product portfolio that biopharma companies rely on for manufacturing.
Roche cans one Carmot obesity asset as another shows best-in-class potential
Roche cans one Carmot obesity asset as another shows best-in-class potential.
Royalty pens $425M deal for slice of AstraZeneca ATTR drug sales
Royalty Pharma penned a $425M deal for a slice of AstraZeneca's ATTR drug sales.
Sanofi gets FDA untitled letter over Beyfortus promotional emails
Sanofi receives an FDA untitled letter calling out Beyfortus (nirsevimab) promotional emails as misleading.
Sanofi reprimanded for disparaging Pfizer's RSV vaccine
Sanofi was reprimanded for disparaging Pfizer's RSV vaccine in marketing materials.
Summit and Akeso sharpen case for ivonescimab with new Western data
Summit Therapeutics and Akeso sharpen the case for ivonescimab with new Western-population clinical data.
Summit has less than a year of cash runway left as PD-1/VEGF verdict nears
Summit has less than a year of cash runway left as PD-1/VEGF verdict nears.
Updated: Summit reports two-year survival data for Western patients, though context lacking
Summit Therapeutics reported two-year survival data for Western patients on ivonescimab, though context was lacking.
Summit updates ivonescimab survival data ahead of PDUFA
In the latest ivonescimab survival data, 'most western patients have now discontinued treatment or completed two years of treatment,' Summit said.
Trump pledges new tariffs on generic drugs not made in the US
Trump pledges new tariffs on generic drugs not made in the US.
Ukraine Ministry of Health Accepts Entolimod Dossier for Formal Review Under Regulatory Equivalence Pathway
Valion Bio announced that Ukraine's Ministry of Health accepted the Company's regulatory dossier for Entolimod.
Vertex was only bidder for Crinetics in year's second-highest M&A premium
Vertex was the only bidder for Crinetics in what became the year's second-highest M&A premium.
Wainua flop narrows AstraZeneca's path to $80B goal ahead of high-risk readouts
With a Phase 3 failure denting the rare disease drug's prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
Wisner Baum's Lawsuits Challenge FDA Oversight of Spinal Cord Implants
Wisner Baum's Lawsuits Challenge FDA Oversight of Spinal Cord Implants.
Lilly, BMS aerospace partner Redwire opens facility in Indiana
Aerospace manufacturer Redwire, a partner of Lilly and BMS, opened a new facility in Indiana.
Aetna Updates Coverage Policy to Include Home Phototherapy for Vitiligo
Phothera announced that Aetna updated its coverage policy to include home phototherapy for vitiligo.
Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset
Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset.
Agios says adios to sickle cell program over lackluster Phase 2 data
Agios said adios to its sickle cell program over lackluster Phase 2 data.
Alembic site hit with warning letter on patient consent concerns
Alembic's bioequivalence site received an FDA warning letter over informed consent concerns.
Investors, Amgen agree to resolve tax bill lawsuit for $74M
Amgen agreed to pay $74 million to resolve an investor lawsuit over a $107 billion tax bill.
Bristol Myers to build 'powerful' AI factory; Samsung Biologics bids for peptide maker
Bristol Myers Squibb announced it would build a 'powerful' AI factory, while Samsung Biologics bids for peptide maker PolyPeptide.
Broad Institute launches Center for Therapeutic Genetics for rare diseases
Broad Institute launches Center for Therapeutic Genetics for rare diseases.
Compounders maintain a firm grip on the GLP-1 market
Compounders maintain a firm grip on the GLP-1 market despite FDA crackdown and pharma lawsuits.
Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review.
Gilead, Merck phase 3 data back first weekly HIV pill
Gilead, Merck phase 3 data back first weekly HIV pill.
GSK shelves cough drug acquired in $2B deal
GSK is shelving its cough drug camlipixant that it acquired in a $2 billion deal.
Is there an exodus underway at Epic?
Is there an exodus underway at Epic?
J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal
J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal.
Jupiter enters psychedelics space with $100M deal for MDMA drug
Jupiter enters psychedelics space with $100M deal for MDMA drug.
Pain drugmaker Latigo outlines plans to go public
Pain drugmaker Latigo outlined plans to go public on NASDAQ under ticker LTGO.
Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
Eli Lilly agreed to buy AtaiBeckley for $2.8 billion, further validating psychedelics research.
Lupin seeds US spinout with cash, clinical-stage cancer assets
Lupin seeds US spinout with cash, clinical-stage cancer assets.
Moderna says CureVac broke agreement by suing over COVID vaccine patents
Moderna says CureVac broke agreement by suing over COVID vaccine patents.
New center launches for personalized genetic therapies
New center launches for personalized genetic therapies.
Notes from a peptide meetup
Notes from a peptide meetup.
For Novartis' CEO, China deals aren't a strategy shift — just where the science is
Novartis' CEO says its latest China deals are not a strategy shift — just following where the science is.
Novartis CEO shrugs off oral PCSK9 threat amid Q2 growth
Novartis CEO shrugs off oral PCSK9 threat amid Q2 growth.
Novartis drops ph. 2-stage radioligand therapy over poor data
Novartis drops ph. 2-stage radioligand therapy over poor data.
Novartis climbs on upbeat drug sales as key readouts loom
Novartis stock climbed on upbeat Q2 drug sales as key readouts loom.
Novartis stays ‘geography-agnostic’ in dealmaking amid flurry of China deals
Novartis stays ‘geography-agnostic’ in dealmaking amid flurry of China deals.
Novo accuses Lilly of running ‘false and misleading’ GLP-1 ads
Novo accuses Lilly of running ‘false and misleading’ GLP-1 ads.
Novo sues Lilly over 'deceptive' ads comparing GLP-1 drug doses
Novo Nordisk sued Eli Lilly over what it calls 'deceptive' ads comparing GLP-1 drug doses.
ORASIS PHARMACEUTICALS DOUBLES DOWN ON EYE CARE PROFESSIONALS, NOT TELEHEALTH, AS QLOSI® REFILLS REACH 49%¹
ORASIS PHARMACEUTICALS DOUBLES DOWN ON EYE CARE PROFESSIONALS, NOT TELEHEALTH, AS QLOSI® REFILLS REACH 49%¹.
Phanes Therapeutics Expands Merck Clinical Trial Collaboration for Biliary Tract Cancer
Phanes Therapeutics expanded its clinical trial collaboration with Merck to evaluate spevatamig in combination with KEYTRUDA for biliary tract cancer.
Samsung Bio to expand its wheelhouse in $1.8B buy for peptide API maker
Samsung Bio to expand its wheelhouse in $1.8B buy for peptide API maker.
Sanofi announces limited changes to its revamped executive team
Sanofi made limited changes to its executive team as new CEO Garijo settles in.
Science and the public are learning the wrong lessons from Covid
Science and the public are learning the wrong lessons from Covid.
Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab
Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab.
Synergy Disc® Reaches 100 U.S. Cases in 100 Days Following FDA Approval, Advancing Motion-Preserving Cervical Disc Replacement in the U.S.
Synergy Disc® Reaches 100 U.S. Cases in 100 Days Following FDA Approval, Advancing Motion-Preserving Cervical Disc Replacement in the U.S..
Tempus to acquire cancer test maker Personalis for $1.5B
Tempus AI agreed to acquire cancer test maker Personalis for $1.5 billion.
THC drinks are sold beside sodas, iced tea, and even chocolate milk, often in violation of state laws
THC drinks are sold beside sodas, iced tea, and even chocolate milk, often in violation of state laws.
Trump administration says it’s deferring $1B in Medicaid payments to California and Minnesota
Trump administration says it’s deferring $1B in Medicaid payments to California and Minnesota.
UnitedHealth Group lays out progress in AI push
UnitedHealth Group lays out progress in AI push.
Why Novartis CEO ended his ADC holdout for $1.5B Myricx deal
Novartis CEO explained why he ended his ADC holdout for the $1.5B Myricx deal.
Why US biotech Axiom is starting its IPO journey in Hong Kong
Why US biotech Axiom is starting its IPO journey in Hong Kong.
2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq
2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq.
ARUP Launches First Clinical Spectral Flow Cytometry Assay for MRD Assessment in Multiple Myeloma
ARUP Launches First Clinical Spectral Flow Cytometry Assay for MRD Assessment in Multiple Myeloma.
Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs.
Bayer's Kerendia on course for NHS use in heart failure
Bayer's Kerendia on course for NHS use in heart failure.
Biohaven to Present New Clinical Data at ESMO Congress on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase I (TopoIx) Payload
Biohaven to Present New Clinical Data at ESMO Congress on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase I (TopoIx) Payload.
BMS, Nvidia aim for ‘most powerful AI factory in life sciences’
BMS, Nvidia aim for ‘most powerful AI factory in life sciences’.
Bristol Myers says it will build pharma's 'most powerful' AI supercomputer with Nvidia
Bristol Myers says it will build pharma's 'most powerful' AI supercomputer with Nvidia.
Consano Bio Receives FDA Investigational New Drug Clearance to Expand the C-1101 Chronic Sciatica Clinical Development Program into the United States
Consano Bio Receives FDA Investigational New Drug Clearance to Expand the C-1101 Chronic Sciatica Clinical Development Program into the United States.
FDA’s radical transparency policy for rejections runs into legal uncertainty
FDA’s radical transparency policy for rejections runs into legal uncertainty.
FDA says Taylor Farms cyclospora finding was a false positive
FDA says Taylor Farms cyclospora finding was a false positive.
Fresenius Medical Care introduces TherapyWise™ analytics for kidney replacement therapy
Fresenius Medical Care introduces TherapyWise™ analytics for kidney replacement therapy.
Geopolitics ‘chills’ British biotech IPO plans, despite VC boost
Geopolitics ‘chills’ British biotech IPO plans, despite VC boost.
GSK abandons cough drug added in $2bn Bellus deal
GSK abandons cough drug added in $2bn Bellus deal.
How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
How Kyverna rode CAR T’s autoimmune wave to the FDA’s door.
J&J, Time to name Healthcare Champion of the Year
J&J, Time to name Healthcare Champion of the Year.
Kolon’s cell-based gene therapy fails ph.3 osteoarthritis test
Kolon’s cell-based gene therapy fails ph.3 osteoarthritis test.
Lilly buys into psychedelics with $3.8bn AtaiBeckley deal
Lilly buys into psychedelics with $3.8bn AtaiBeckley deal.
Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics.
MSD gets first FDA okay for oral PCSK9 cholesterol drug
MSD gets first FDA okay for oral PCSK9 cholesterol drug.
Novo's Wegovy pill cleared for weight loss in EU
Novo's Wegovy pill cleared for weight loss in EU.
Rebel Wilson talks losing weight 'for keeps' in Noom campaign
Rebel Wilson talks losing weight 'for keeps' in Noom campaign.
Samsung Bio set to launch $1.8B buyout of Swiss CDMO PolyPeptide
Samsung Bio set to launch $1.8B buyout of Swiss CDMO PolyPeptide.
Samsung Biologics to launch $1.8 billion all-cash bid for PolyPeptide
Samsung Biologics to launch $1.8 billion all-cash bid for PolyPeptide.
Sanofi survey reveals diabetes misconceptions and screening gaps
Sanofi survey reveals diabetes misconceptions and screening gaps.
Scribe aims for $96M IPO to fund lipid-lowering genetic meds
Scribe aims for $96M IPO to fund lipid-lowering genetic meds.
Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence.
UK biotech VC funding rebounds and reaches record high
UK biotech VC funding rebounds and reaches record high.
Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals.
Why Legend Biotech stock fell 10% despite record Carvykti sales
Why Legend Biotech stock fell 10% despite record Carvykti sales.
Why other Big Pharmas could follow Lilly into psychedelics
Why other Big Pharmas could follow Lilly into psychedelics.
Latigo preps IPO to fund non-opioid rival to Vertex’s Journax
Latigo preps IPO to fund non-opioid rival to Vertex’s Journax.
Biogen’s mixed Alzheimer’s data; Two new startups launch; and more
Biogen’s mixed Alzheimer’s data; Two new startups launch; and more.
Celcuity got its cancer drug approved. Then its stock dipped
Celcuity got its cancer drug approved. Then its stock dipped.
Midsized biotechs take case against CMS' GLOBE and GUARD models to White House
Midsized biotechs take case against CMS' GLOBE and GUARD models to White House.
Salus Scientific Welcomes Landmark Multi-Society Consensus Statement Advancing the Standard of Care for Severe Burn Injuries
Salus Scientific issued a statement welcoming a multi-society consensus statement that advances the standard of care for severe burn injuries; the company markets burn-care and resuscitation products.
Salus Scientific Welcomes Landmark Multi-Society Consensus Statement Advancing the Future of Occupational Radiation Safety
Salus Scientific Welcomes Landmark Multi-Society Consensus Statement Advancing the Future of Occupational Radiation Safety.
2026 IPO stock tracker: How biotechs new to public markets are performing
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
5 emerging biotech hubs
Fierce Biotech profiles five emerging biotech hubs to watch.
ANF Care™ Brings New Wearable Technology to the United States
ANF Care announced US market entry for its ANF Care wearable therapeutic device, expanding availability of its frequency-based wearable technology to American patients and clinicians.
APhA urges FDA to put patient safety first in review of peptide substances
The American Pharmacists Association (APhA) submitted formal comments to the FDA urging the agency to prioritize patient safety in its ongoing review of peptide substances, including compounded and bulk-drug substances.
Arbutus, Sanofi escalate mRNA patent fights; InnoCare's TYK2 contender advances
Arbutus, Sanofi escalate mRNA patent fights; InnoCare's TYK2 contender advances.
BlossomHill eyes IPO to grow taller in crowded cancer fields
BlossomHill eyes IPO to grow taller in crowded cancer fields.
BRIJ Medical Launches BRIJ-SEAL™, Expanding Its Incision Management Portfolio with New Topical Skin Closure Solution
BRIJ Medical announced the US launch of BRIJ-SEAL™, a topical skin closure product, expanding the company's incision management portfolio alongside its existing wound-closure and post-operative care products.
BRIJ Medical Launches BRIJ-SEAL™, Expanding Its Incision Management Portfolio with an Advanced Wound Sealant
BRIJ Medical Launches BRIJ-SEAL™, Expanding Its Incision Management Portfolio with an Advanced Wound Sealant.
Camurus' NDA resubmission for CAM2029 in acromegaly accepted for review by the US FDA
Camurus announces that the FDA has accepted for review its NDA resubmission for CAM2029 in acromegaly.
Can the shingles vaccine prevent Alzheimer's? GSK has a big study to find out
GSK launches a large study to test whether the shingles vaccine can prevent dementia.
Can ultrasound unlock the power of gene therapy? A startup makes big claims
Sonathera claims ultrasound can unlock the power of gene therapy in Duchenne and other diseases.
Cue lines up new CMO and research head—Chutes & Ladders
Cue Health lines up a new CMO and research head in the latest Chutes & Ladders roundup.
Cue lines up new CMO and research head—Chutes & Ladders
Cue Health lines up a new CMO and research head in the latest Chutes & Ladders roundup.
Dimerix buys a kidney injury drug; Arpeggio appears to be winding down
Dimerix buys a kidney injury drug from Mission; Arpeggio appears to be winding down.
Dimerix buys Mission's kidney disease prospect in $292M deal
Dimerix acquires Mission Therapeutics' kidney disease prospect for $292M with $5M upfront.
FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol.
FDA grants full approval to Novartis' Fabhalta in IgAN
FDA grants full approval to Novartis' Fabhalta in IgAN.
Foundation Medicine starts push to stand out in cancer testing
Foundation Medicine launches a 'quality-first' initiative to stand out in cancer testing.
GSK axes key cough drug candidate after phase 3 data disappoint
GSK discontinues its chronic cough drug candidate from the Bellus acquisition after Phase 3 disappointment.
GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
GSK discontinues its Phase 3 chronic cough program from the $2B Bellus Health acquisition.
GSK drops Phase 3 chronic cough drug in a blow to $2B Bellus Health buyout
GSK drops its Phase 3 chronic cough drug from the $2B Bellus Health buyout.
GSK-Hansoh, Merck-Kelun, AZ-Dizal—Fierce Pharma Asia
Asia roundup: GSK-Hansoh, Merck-Kelun, AZ-Dizal ADC wins and a $1.5B EGFR deal.
Insmed moves closer to $6B opportunity as PAH drug shows long-term durability
Insmed's PAH drug shows long-term durability data supporting a $6B market opportunity.
Jasper gets a lifeline in merger with immune drugmaker Kira
Jasper gets a lifeline in merger with immune drugmaker Kira.
Jasper merges with Kira, while Tavneos rival sent to Mirador
Jasper merges with Kira to reach public markets; a Tavneos rival is sent to Mirador.
Lettuce at Taco Bell in five states confirmed as a source of diarrhea-causing parasite
CDC confirms Taylor Farms lettuce at Taco Bell as the source of a multistate cyclosporiasis outbreak.
MAHA is rewriting the vocabulary of American mental health care
MAHA rhetoric is reshaping the language of mental health care in America.
Mirador unveils a piece of pipeline with drug from Kira to rival troubled Tavneos
Mirador unveils a pipeline piece licensed from Kira to rival the troubled Tavneos.
Novo, Alvotech written up after FDA site inspections
FDA disclosed concerns raised during recent visits to manufacturing sites tied to Novo and Alvotech.
Poriferous, LLC Secures Patent for DuraBloc™ Technology
Poriferous, LLC announced issuance of a US patent covering its DuraBloc™ surgical adhesion barrier technology, expanding IP protection for the company's implantable medical device platform.
Quitting smoking is hard. A Medicare change may push doctors to give more help
STAT News reports on a Medicare coverage change intended to expand reimbursement for smoking-cessation counseling, potentially giving clinicians a stronger incentive to provide cessation support to beneficiaries.
Tagrisso-chasing BlossomHill enters Nasdaq queue as biotech IPOs flourish
BlossomHill Therapeutics enters the Nasdaq queue with a Tagrisso-chasing oncology program.
The Oral GLP-1 Tracker: Lilly's Foundayo scripts tick up
Lilly's oral GLP-1 Foundayo continues to climb in early scripts versus Novo's Wegovy pill.
The Readout
The Readout.
UK's Mission divests kidney drug to Dimerix for $292m
Mission Therapeutics out-licenses a kidney drug to Dimerix for $292m.
Zealand Pharma gets its US marketing leader from Lilly; Bexorg turns to Biohaven for CSO hire
Zealand Pharma hires its US marketing leader from Lilly; Bexorg brings in a CSO from Biohaven.
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