CART Blood Pressure Monitor Demonstrates Utility in BP Monitoring for AF and Heart Failure Patients
A new blood pressure monitor from CART demonstrates clinical utility for monitoring patients with atrial fibrillation and heart failure.
Biopharm & Life Sciences Intelligence
The definitive intelligence hub for biopharmaceuticals, clinical developments, stock market indicators, and biotechnology careers.
Latest Intelligence Updates
Claret says its latest fund will have larger focus on European life sciences
Venture capital firm Claret announces its latest fund will expand its focus on European life sciences investments.
Novartis' Phase 3 cardiovascular study miss raises the stakes for Amgen, Lilly
Novartis' Phase 3 pelacarsen study miss in cardiovascular disease raises competitive stakes for Amgen and Eli Lilly in the space.
Prospects for Novo's CKD program narrow as ph. 3 trials scrapped
Novo Nordisk's blockbuster hopes for its chronic kidney disease program dwindle after additional Phase 3 trials are scrapped.
AbbVie-backed ADARx plans IPO to fund array of siRNA med trials
AbbVie-backed ADARx Pharmaceuticals plans an IPO to fund its clinical-stage siRNA therapy pipeline.
AZ goes full AI-animal in new Breztri ad
AstraZeneca launches a new AI-generated ad campaign featuring a llama to promote its Breztri combination inhaler for COPD.
A global health cash crunch could jeopardize the race for new Ebola vaccines
Funding shortfalls in global health programs threaten the development and deployment of next-generation Ebola vaccines.
What STAT readers think about M.D. vs. D.O., AI in medicine, surrogacy, and more
What STAT readers think about M.D. vs. D.O., AI in medicine, surrogacy, and more
10 life sciences startups selected for accelerator program
Article from BioSpace about 10 life sciences startups selected for accelerator program.
AbbVie-allied ADARx aims to go public with 3 drugs in the clinic
ADARx Pharmaceuticals, allied with AbbVie, files for an IPO with three RNA-based therapeutics advancing through clinical trials.
Daiichi unit recalls 3 epinephrine lots after complaints in US
Daiichi unit recalls 3 epinephrine lots after complaints in US
Enhertu OK ends 10-year EU gap in frontline breast cancer
Article from Pharmaphorum about Enhertu OK ends 10-year EU gap in frontline breast cancer.
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
Former I-Mab chief Joan Shen's NeuShen banks $80M+ for 3 brain-health drugs
NeuShen Therapeutics, founded by former I-Mab CEO Joan Shen, raises over $80 million to develop three brain-health drug candidates.
Hutchmed rises on $1.3bn KRAS licensing deal with GSK
Article from Pharmaphorum about Hutchmed rises on $1.3bn KRAS licensing deal with GSK.
Invivyd's chair adds CEO role ahead of readout—Chutes & Ladders
Article from Fierce Biotech about Invivyd's chair adds CEO role ahead of readout—Chutes & Ladders.
Ionis scores ‘breakthrough’ rare disease approval
Ionis scores ‘breakthrough’ rare disease approval
Ionis wins FDA clearance for Alexander disease drug, company's first solo neurology approval
Ionis Pharmaceuticals receives FDA approval for its Alexander disease drug zilganersen, marking the company's first solo neurology approval.
Italy's Menarini gets into obesity with European rights to GLP-1 from China's Gan & Lee
Italian pharmaceutical company Menarini secures European rights to a GLP-1 obesity drug from China's Gan & Lee Pharmaceuticals.
Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP
Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP
Menarini inks $771M deal to take Gan & Lee GLP-1 to Europe
Article from Fierce Biotech about Menarini inks $771M deal to take Gan & Lee GLP-1 to Europe.
Merck's M&A chief expects 'a lot more deal flow' as Keytruda patent cliff nears
Merck's head of M&A signals increased deal-making activity as the Keytruda patent expiration approaches.
Morning Rounds
STAT News daily newsletter covering health policy, disability insurance risks, and the latest in medical research.
Novartis' drug delivery deal with Alteogen; More worker cuts at Cellares
Novartis signs a drug delivery technology deal with Alteogen while Cellares implements further workforce reductions.
Novartis halts CAR-T trials after patient deaths
Article from Pharmaphorum about Novartis halts CAR-T trials after patient deaths.
Novartis Lp(a) drug fails closely watched ph. 3 trial
Novartis Lp(a) drug fails closely watched ph. 3 trial
Pfizer punts Seagen ADC, further muddying value of the $43B buyout
Pfizer punts Seagen ADC, further muddying value of the $43B buyout
Roche, GSK, Novartis, MFN, Akeso and more—Fierce Pharma Asia
Article from Fierce Pharma about Roche, GSK, Novartis, MFN, Akeso and more—Fierce Pharma Asia.
Roche taps Simcere for autoimmune trispecific for $1.53bn
Article from Pharmaphorum about Roche taps Simcere for autoimmune trispecific for $1.53bn.
The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the fear remains
Article from STAT News about The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the f.
The people who stayed with the problem
A look at the pharmaceutical professionals who persevered through industry challenges and continued working on difficult drug development programs.
Thiel-backed Lindus pivots to hunting external drug assets after CRO-arm sale
Lindus Health, backed by Peter Thiel, sells its CRO division and pivots to in-licensing external pharmaceutical assets.
White House signs pricing deals with nine more pharmas
Article from Pharmaphorum about White House signs pricing deals with nine more pharmas.
Withings Introduces StethO Sense, Bringing Heart and Lung Sound Analysis to BeamO
Withings Introduces StethO Sense, Bringing Heart and Lung Sound Analysis to BeamO
A year after Big Pharma’s pull-back from the UK, what's changed?
Article from Fierce Biotech about A year after Big Pharma’s pull-back from the UK, what's changed?.
AbbVie bispecific shows promise in ph. 3 multiple myeloma trial
AbbVie bispecific shows promise in ph. 3 multiple myeloma trial
AbbVie’s T cell engager delivers survival benefit in Phase 3 multiple myeloma study
Article from BioSpace about AbbVie’s T cell engager delivers survival benefit in Phase 3 multiple myeloma study.
Akeso, Summit’s ivonescimab hits OS goal in Keytruda head-to-head
Akeso, Summit’s ivonescimab hits OS goal in Keytruda head-to-head
Biopharma needs more data scientists. Who’s getting hired?
Biopharma needs more data scientists. Who’s getting hired?
Capricor, Replimune illustrate why FDA must listen to rare disease specialists
Article from BioSpace about Capricor, Replimune illustrate why FDA must listen to rare disease specialists.
CAR-T deaths prompt halt by Novartis; Eli Lilly’s 13th acquisition of 2026; and more
Novartis halts CAR-T trial after patient deaths; Eli Lilly makes its13th acquisition of2026; and other industry news.
CBER official overruled review team's rejection of new Replimune melanoma drug
A CBER official overruled the review team's rejection of Replimune's new melanoma drug, raising questions about FDA decision-making.
CMI forms new specialty communications business unit
CMI forms new specialty communications business unit
Deaths in Novartis CAR-T trial force a reckoning over acceptable risk in autoimmune disease
Patient deaths in a Novartis CAR-T cell therapy trial raise fundamental questions about acceptable risk in autoimmune disease treatment.
FDA Approves First Drug to Treat Alexander Disease
Article from FDA Newsroom about FDA Approves First Drug to Treat Alexander Disease.
FDA approves Ionis’ antisense drug as first targeted therapy for Alexander disease
Article from BioSpace about FDA approves Ionis’ antisense drug as first targeted therapy for Alexander disease.
FDA conveys tougher clamp down of foreign trial data coinciding with China’s rise
FDA officials signal enhanced scrutiny of foreign clinical trial data, coinciding with the rise of China-based biopharma companies.
FDA docs shed light on contentious nod for Replimune's Trudiqev
Article from Fierce Pharma about FDA docs shed light on contentious nod for Replimune's Trudiqev.
FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats
FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats
FDA Seeks Public Input to Advance Development of Botanical Drug Products
FDA Seeks Public Input to Advance Development of Botanical Drug Products
Fresenius Medical Care hit with FDA warning letter at Utah plant
Article from Fierce Pharma about Fresenius Medical Care hit with FDA warning letter at Utah plant.
GSK inks another Asia alliance, betting up to $1.3B for HUTCHMED’s cancer therapy
GSK inks another Asia alliance, betting up to $1.3B for HUTCHMED’s cancer therapy
GSK pens $1.3B Hutchmed deal for KRAS-EGFR cancer asset
GSK pens $1.3B Hutchmed deal for KRAS-EGFR cancer asset
GSK to license Hutchmed’s dual-action cancer drug for $110M upfront
GSK licenses HUTCHMED's dual-action KRAS/EGFR cancer drug in a deal worth $110 million upfront plus milestones.
Kali Therapeutics Receives U.S. FDA Clearance for KT501 Investigational New Drug Application
Article from PR Newswire FDA about Kali Therapeutics Receives U.S. FDA Clearance for KT501 Investigational New Drug Application.
Matricelf Receives FDA Feedback Supporting Key Elements of Proposed First in Human Clinical Trial for NewRal Spinal Cord Injury Program
Matricelf Receives FDA Feedback Supporting Key Elements of Proposed First in Human Clinical Trial for NewRal Spinal Cord Injury Program
Novartis teams with Olympian Laviai Nielsen on MS campaign
Article from Fierce Pharma about Novartis teams with Olympian Laviai Nielsen on MS campaign.
Pfizer offloads scrapped Seagen ADC to Medicus Pharma
Pfizer divests a discontinued Seagen antibody-drug conjugate to Medicus Pharma in a deal valued at up to $1 billion.
Physicians
New study shows drug overdose deaths have declined sharply, according to Commonwealth Fund research.
Psilocybin proves promising in neuropathic pain mouse study
Article from Fierce Biotech about Psilocybin proves promising in neuropathic pain mouse study.
Replimune’s melanoma drug would have been rejected again if not for senior CBER official
Replimune’s melanoma drug would have been rejected again if not for senior CBER official
RevMed’s newly approved Rasonque could ‘hold up’ in non-small cell lung cancer
RevMed’s newly approved Rasonque could ‘hold up’ in non-small cell lung cancer
Summit, Akeso’s ivonescimab bests Merck’s Keytruda in China trial—again
Summit, Akeso’s ivonescimab bests Merck’s Keytruda in China trial—again
Superluminal secures $60M for Phase 1 of genetic obesity drug
Superluminal Medicines raises $60 million to advance its genetic obesity drug candidate into Phase1clinical trials.
‘Tactical athletes’ get new guidance for cardiovascular fitness
New cardiovascular fitness guidelines issued for tactical athletes including military, law enforcement, and first responders.
The pediatricians who take in vaccine-skeptical parents others won’t
How some pediatricians are building trust with vaccine-hesitant families that other providers have turned away.
TScan cuts 75% of workforce while shifting focus to solid tumor program
TScan cuts 75% of workforce while shifting focus to solid tumor program
Ultragenyx fails ph. 3 Angelman test as shares tumble
Ultragenyx fails ph. 3 Angelman test as shares tumble
Ultragenyx’s ‘high-risk’ Angelman bet fails, cratering stock and forcing strategic review
Ultragenyx’s ‘high-risk’ Angelman bet fails, cratering stock and forcing strategic review
US to grant up to $125M for personalized RNA manufacturing innovation
US to grant up to $125M for personalized RNA manufacturing innovation
Why Roche is 'really excited' about UCN2's obesity potential
Why Roche is 'really excited' about UCN2's obesity potential
ARPA-H awards $125M for manufacturing custom RNA therapies on demand
ARPA-H awards $125 million to develop on-demand manufacturing capabilities for custom RNA therapies.
ARPA-H taps 5 teams to help streamline RNA therapy production
ARPA-H taps 5 teams to help streamline RNA therapy production
Arsenal Biosciences cuts ‘majority’ of staff in move to in vivo CAR-T
Arsenal Biosciences lays off the majority of its workforce as it pivots from ex vivo to in vivo CAR-T cell therapy development.
Bayesian Health's FDA-Cleared Continuous AI Sepsis Monitor Approved for Medicare New Technology Add-on Payment (NTAP)
Bayesian Health's FDA-Cleared Continuous AI Sepsis Monitor Approved for Medicare New Technology Add-on Payment (NTAP)
Biopharma reverse mergers rise 1,600% in Q3 to rival IPOs
Biopharma reverse mergers rise 1,600% in Q3 to rival IPOs
Cellares trims more roles after losing a key client
Cellares trims more roles after losing a key client
China deaths reignite debate about using viruses to deliver CRISPR therapies
Deaths in a Chinese clinical trial reignite the debate about the safety of using viral vectors to deliver CRISPR gene therapies.
CytoSorbents Announces New Real-World Data Demonstrating Significant Reduction in Severe Bleeding Using CytoSorb in CABG Patients on Ticagrelor and Updates Recent DrugSorb-ATR FDA Pre-Submission Meetings
CytoSorbents Announces New Real-World Data Demonstrating Significant Reduction in Severe Bleeding Using CytoSorb in CABG Patients on Ticagrelor and Updates Recent DrugSorb-ATR FDA Pre-Submission Meetings
Doctors groups release vaccination guidelines ahead of respiratory illness season
Article from STAT News about Doctors groups release vaccination guidelines ahead of respiratory illness season.
FDA Allows First Gene Therapy Clinical Trial for Ultra-Rare Pediatric Neurodegenerative Disease
FDA Allows First Gene Therapy Clinical Trial for Ultra-Rare Pediatric Neurodegenerative Disease
FDA raises bar for foreign site inspections as China trials surge
FDA raises bar for foreign site inspections as China trials surge
Fortrea boosts early-phase platform with $45M acquisition
Fortrea boosts early-phase platform with $45M acquisition
Foventa further strengthens management team with key CMO and CFO appointments
Foventa further strengthens management team with key CMO and CFO appointments
Hamamatsu Receives FDA 510(k) Clearance for NanoZoomer S20MD and S540MD Slide scanner systems
Hamamatsu Receives FDA 510(k) Clearance for NanoZoomer S20MD and S540MD Slide scanner systems
Inside Absci's quest to become the Apple of biotech
Inside Absci's quest to become the Apple of biotech
New HCPCS Billing Code Enables Medicare Benefit Billing of Lasix® ONYU When Furnished Incident to a Physician's Service
New HCPCS Billing Code Enables Medicare Benefit Billing of Lasix® ONYU When Furnished Incident to a Physician's Service
Norroy Bioscience Initiates Pivotal Phase III Clinical Trial of 177Lu-NYM032, a PSMA-Targeted Radioligand Therapy for mCRPC
Norroy Bioscience Initiates Pivotal Phase III Clinical Trial of 177Lu-NYM032, a PSMA-Targeted Radioligand Therapy for mCRPC
Novartis’ and BMS’ paused CAR T trials, RevMed’s pancreatic cancer approval, more MFN deals
Novartis’ and BMS’ paused CAR T trials, RevMed’s pancreatic cancer approval, more MFN deals
Novartis’ Rhapsido cuts MS progression in Phase 3 trial, teeing up Roche battle
Novartis’ Rhapsido cuts MS progression in Phase 3 trial, teeing up Roche battle
Novartis telegraphs 130 job cuts in Switzerland
Novartis telegraphs 130 job cuts in Switzerland
Roche finds another oncology gem in Asia with $1.5B B cell disease partnership
Roche finds another oncology gem in Asia with $1.5B B cell disease partnership
Stripped of AstraZeneca safety net, BMS could face ‘carnage’ if high-risk clinical trial fails
Stripped of AstraZeneca safety net, BMS could face ‘carnage’ if high-risk clinical trial fails
Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing
Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing
Three takeaways from the latest White House drug pricing event
Key takeaways from the latest White House drug pricing event, including new pricing agreements with pharmaceutical companies.
Trump’s Medicare GLP-1 update teases blockbuster sales for Lilly
Trump’s Medicare GLP-1 update teases blockbuster sales for Lilly
UniQure files for FDA, UK approval of first gene therapy for Huntington’s disease
UniQure files for FDA, UK approval of first gene therapy for Huntington’s disease
9 midsize drugmakers climb aboard Trump’s MFN train
9 midsize drugmakers climb aboard Trump’s MFN train. Published by BioSpace on 2026-09-01.
Alumis crushed by midstage lupus flop but plots path to phase 3
Alumis crushed by midstage lupus flop but plots path to phase 3. Published by Fierce Biotech on 2026-09-01.
Alumis falls after TYK2 pill fails lupus study, but CEO sees 'clear path forward'
Alumis falls after TYK2 pill fails lupus study, but CEO sees 'clear path forward'. Published by Endpoints News on 2026-09-01.
ARCH Venture Partners targets $3 billion raise for latest fund
ARCH Venture Partners targets $3 billion raise for latest fund. Published by Endpoints News on 2026-09-01.
ArsenalBio sacrifices ‘majority’ of staff in pivot to in vivo CAR T
ArsenalBio sacrifices ‘majority’ of staff in pivot to in vivo CAR T. Published by BioSpace on 2026-09-01.
ArsenalBio sheds most of staff in pivot to in vivo CAR-T
ArsenalBio sheds most of staff in pivot to in vivo CAR-T. Published by Fierce Biotech on 2026-09-01.
As MAHA champions nutrition, it’s ignoring the experts, dietitians say
As MAHA champions nutrition, it’s ignoring the experts, dietitians say. Published by STAT News on 2026-09-01.
FDA Approves Ionis Pharma Drug, the First for Ultra-Rare Alexander Disease
FDA Approves Ionis Pharma Drug, the First for Ultra-Rare Alexander Disease
GSK Pays $110M for Phase 1-Ready Hutchmed Asset in a New Class of Cancer Drugs
GSK acquires global rights to Hutchmed's Phase 1-ready antibody-targeted therapy conjugate for $110 million upfront, targeting lung, colorectal, and pancreatic cancers.
GSK plans phase 3 after mRNA flu vaccine beats standard shots
GSK plans phase 3 after mRNA flu vaccine beats standard shots. Published by Fierce Biotech on 2026-09-01.
GSK to advance mRNA flu vaccine to late-stage trial
GSK advances its mRNA-based influenza vaccine into late-stage clinical trials.
GSK to launch Phase 3 test of mRNA flu vaccine with newer formulation
GSK to launch Phase 3 test of mRNA flu vaccine with newer formulation. Published by Endpoints News on 2026-09-01.
GSK to launch Phase 3 trial for mRNA-based flu vaccine amid resurgence for the modality
GSK to launch Phase 3 trial for mRNA-based flu vaccine amid resurgence for the modality. Published by BioSpace on 2026-09-01.
GSK's Pivotal Test for mRNA Flu Vaccine Aims to Show Two Targets Are Better Than One
GSK's Pivotal Test for mRNA Flu Vaccine Aims to Show Two Targets Are Better Than One
K Health is eyeing an IPO by 2029
K Health is eyeing an IPO by 2029. Published by Endpoints News on 2026-09-01.
Lilly’s dealmaking spreads the wealth among a broad set of biotech venture investors
Lilly’s dealmaking spreads the wealth among a broad set of biotech venture investors. Published by Endpoints News on 2026-09-01.
Medibyt Receives FDA 510(k) Clearance for CPETWise, Advancing Cardiopulmonary Exercise Test Analysis and Interpretation
Medibyt Receives FDA 510(k) Clearance for CPETWise, Advancing Cardiopulmonary Exercise Test Analysis and Interpretation. Published by PR Newswire FDA on 2026-09-01.
North Carolina Approves Reimbursement of VR Therapy for Neurodivergent Residents Under NC Innovations Waiver
North Carolina Approves Reimbursement of VR Therapy for Neurodivergent Residents Under NC Innovations Waiver. Published by PR Newswire FDA on 2026-09-01.
Novartis' BTK drug clears ph. 3 in MS sans liver safety signal
Novartis' BTK drug clears ph. 3 in MS sans liver safety signal. Published by Fierce Pharma on 2026-09-01.
Novartis' Rhapsido safer than rivals, Phase 3 multiple sclerosis data suggest
Novartis' Rhapsido safer than rivals, Phase 3 multiple sclerosis data suggest. Published by Endpoints News on 2026-09-01.
Roche inks $1.53B deal for Simcere’s B-cell-targeting antibody
Roche inks $1.53B deal for Simcere’s B-cell-targeting antibody. Published by Fierce Biotech on 2026-09-01.
Roche signs trispecific T cell engager pact with Simcere in another China deal
Roche signs trispecific T cell engager pact with Simcere in another China deal. Published by Endpoints News on 2026-09-01.
Stryker introduces first of its kind FDA-authorized surgical application for Apple Vision Pro with hip arthroscopy case at nationally recognized academic medical center
Stryker introduces first of its kind FDA-authorized surgical application for Apple Vision Pro with hip arthroscopy case at nationally recognized academic medical center. Published by PR Newswire FDA on 2026-09-01.
Teva Drug Rises to the Gluten Challenge, Stopping Intestinal Damage in Celiac Disease Trial
Teva Drug Rises to the Gluten Challenge, Stopping Intestinal Damage in Celiac Disease Trial
The Trump administration is burying science and health care in paperwork
The Trump administration is burying science and health care in paperwork. Published by STAT News on 2026-09-01.
Three deaths in CAR-T trials prompt halt by Novartis; Bristol Myers programs also paused
Three deaths in CAR-T trials prompt halt by Novartis; Bristol Myers programs also paused. Published by Endpoints News on 2026-09-01.
Trump announces nine new drug pricing deals, this time with midsize biotechs
Trump announces nine new drug pricing deals, this time with midsize biotechs. Published by Endpoints News on 2026-09-01.
Ultragenyx Trial Failure Revives Debate About How to Treat a Rare Neuro Disorder
Article from MedCity News about Ultragenyx Trial Failure Revives Debate About How to Treat a Rare Neuro Disorder.
Veeva Falcon Safety to Work with All E2B-Compliant Safety Systems Across Any Intake Channels
Veeva Falcon Safety to Work with All E2B-Compliant Safety Systems Across Any Intake Channels. Published by PR Newswire FDA on 2026-09-01.
Amai Proteins' sweelin® Approved for Sale in Israel, Opening the Market to a New Generation of Reduced-Sugar Food and Beverage Products
Amai Proteins' sweelin® Approved for Sale in Israel, Opening the Market to a New Generation of Reduced-Sugar Food and Beverage Products
Arrowhead claims safety edge over Ionis as triglyceride battle draws closer
Arrowhead claims safety edge over Ionis as triglyceride battle draws closer
Arrowhead’s new Redemplo findings in severe hypertriglyceridemia have analysts split
Arrowhead’s new Redemplo findings in severe hypertriglyceridemia have analysts split
Ascendis pays 20% royalties in patent settlement with BioMarin
Ascendis pays 20% royalties in patent settlement with BioMarin. Published by Fierce Pharma on 2026-08-31.
AstraZeneca's heart failure drug shows promise in ph. 2 trial
AstraZeneca's heart failure drug shows promise in ph. 2 trial. Published by Fierce Biotech on 2026-08-31.
AstraZeneca's relaxin pill shows promise in mid-stage heart failure trial
AstraZeneca's relaxin pill shows promise in mid-stage heart failure trial
Biomarin nabs big royalties in achondroplasia patent settlement with Ascendis
Biomarin nabs big royalties in achondroplasia patent settlement with Ascendis. Published by BioSpace on 2026-08-31.
BMS’ neuro renaissance was built on back of Celgene mega-merger
BMS’ neuro renaissance was built on back of Celgene mega-merger
China poses increasing security risk as US biotech innovation edge erodes
China poses increasing security risk as US biotech innovation edge erodes
Deal-hungry Lilly strikes up to $2.9B immuno play for Merida
Deal-hungry Lilly strikes up to $2.9B immuno play for Merida
Electra aims to light up Nasdaq with IPO for phase 2/3 I&I push
Electra aims to light up Nasdaq with IPO for phase 2/3 I&I push. Published by Fierce Biotech on 2026-08-31.
Emergent spreads overdose awareness campaign across US, Canada
Emergent spreads overdose awareness campaign across US, Canada. Published by Fierce Pharma on 2026-08-31.
FDA approves label expansion for PharmaEssentia's Besremi
FDA approves label expansion for PharmaEssentia's Besremi
FDA dings Alar over ‘extremely concerning’ ketamine claims
FDA dings Alar over ‘extremely concerning’ ketamine claims. Published by Fierce Pharma on 2026-08-31.
Jazz’s Ziihera secures 2nd survival win in HER2+ stomach cancer
Jazz’s Ziihera secures 2nd survival win in HER2+ stomach cancer
Karyopharm Submits Supplemental New Drug Application to the FDA for XPOVIO® (selinexor) Plus Ruxolitinib for Patients with Myelofibrosis
Karyopharm Submits Supplemental New Drug Application to the FDA for XPOVIO® (selinexor) Plus Ruxolitinib for Patients with Myelofibrosis
Lilly inks $2.88B Merida buyout to expand autoimmune pipeline
Lilly inks $2.88B Merida buyout to expand autoimmune pipeline
Lilly to buy TED startup Merida Biosciences in its 13th acquisition of 2026
Lilly to buy TED startup Merida Biosciences in its 13th acquisition of 2026
Lonza enlists returning exec for new commercial chief post
Lonza enlists returning exec for new commercial chief post. Published by Fierce Pharma on 2026-08-31.
New guidelines on migraine prevention reflect increasing options for patients
New guidelines on migraine prevention reflect increasing options for patients. Published by STAT News on 2026-08-31.
Novartis halts autoimmune CAR-T trials after 3 deaths
Novartis halts autoimmune CAR-T trials after 3 deaths. Published by Fierce Biotech on 2026-08-31.
Novartis pauses CAR T studies due to 3 deaths; BMS follows suit after safety events
Novartis pauses CAR T studies due to 3 deaths; BMS follows suit after safety events. Published by BioSpace on 2026-08-31.
Samsung Biologics to launch takeover bid for PolyPeptide in September
Samsung Biologics to launch takeover bid for PolyPeptide in September
Sanofi-backed Electra files for IPO to fund Phase 2/3 immunology drug
Sanofi-backed Electra files for IPO to fund Phase 2/3 immunology drug
T-MAXIMUM B7-H3-Targeted Allogeneic CAR-T Therapy MT027 Receives FDA Fast Track Designation, Accelerating Global Development for Intracranial Solid Tumors
T-MAXIMUM B7-H3-Targeted Allogeneic CAR-T Therapy MT027 Receives FDA Fast Track Designation, Accelerating Global Development for Intracranial Solid Tumors
Takeda, Protagonist score broad FDA nod in rare blood cancer, setting up $2B opportunity
Takeda, Protagonist score broad FDA nod in rare blood cancer, setting up $2B opportunity
The GLP-like race to keep us awake and make billions doing it
The GLP-like race to keep us awake and make billions doing it. Published by Fierce Biotech on 2026-08-31.
The most shocking thing about the latest statistics on CTE in football is that we find them so shocking
The most shocking thing about the latest statistics on CTE in football is that we find them so shocking
The Readout
The Readout
Trump administration announces drug pricing deals with CSL, Astellas and others, includes video
The Trump administration announces new drug pricing agreements with CSL, Astellas, and other pharmaceutical companies.
UCB Comes to Agreement with U.S. Government to Lower the Cost of Medicine and Strengthen U.S. Manufacturing
UCB Comes to Agreement with U.S. Government to Lower the Cost of Medicine and Strengthen U.S. Manufacturing. Published by PR Newswire FDA on 2026-08-31.
Ultra Violette Becomes First Brand in the US to Launch a Sunscreen Containing Newly FDA-Approved Filter Bemotrizinol
Ultra Violette Becomes First Brand in the US to Launch a Sunscreen Containing Newly FDA-Approved Filter Bemotrizinol. Published by PR Newswire FDA on 2026-08-31.
Veloxis Pharmaceuticals Doses First Patient in RENGEVITY-201 Phase 2 Trial of Pegrizeprument for the Prevention of Organ Rejection in Kidney Transplant Recipients
Veloxis Pharmaceuticals Doses First Patient in RENGEVITY-201 Phase 2 Trial of Pegrizeprument for the Prevention of Organ Rejection in Kidney Transplant Recipients
White House unveils next round of MFN drug pricing deals
White House unveils next round of MFN drug pricing deals. Published by Fierce Pharma on 2026-08-31.
Ziihera® (zanidatamab-hrii) plus Chemotherapy Demonstrates Statistically Significant Overall Survival Benefit Versus Trastuzumab plus Chemotherapy in First-Line HER2+ Advanced GEA
Ziihera® (zanidatamab-hrii) plus Chemotherapy Demonstrates Statistically Significant Overall Survival Benefit Versus Trastuzumab plus Chemotherapy in First-Line HER2+ Advanced GEA
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