Akeso details survival win for its PD-1xVEGF drug versus Keytruda
Akeso reports strong overall survival data for its PD-1xVEGF bispecific antibody ivonescimab, demonstrating superiority over Keytruda in PD-L1-high NSCLC.
The definitive intelligence hub for biopharmaceuticals, clinical developments, stock market indicators, and biotechnology careers.
Akeso reports strong overall survival data for its PD-1xVEGF bispecific antibody ivonescimab, demonstrating superiority over Keytruda in PD-L1-high NSCLC.
Akeso's ivonescimab achieves superior overall survival versus Keytruda in PD-L1-high non-small cell lung cancer, marking a significant competitive threat to Merck's blockbuster drug.
AstraZeneca's oral SERD Etcamah fails to meet primary endpoint in first-line breast cancer trial, adding to the company's setbacks in this drug class.
Merck and Gilead's Trodelvy shows improved results in Chinese patients with first-line NSCLC, despite the global trial failing to meet its primary endpoint.
FDA extends its review period for Exelixis' colorectal cancer drug candidate, delaying the anticipated approval decision.
GSK's antibody-drug conjugate demonstrates competitive efficacy in lung cancer, positioning it as a challenger to Merck's dominant Keytruda franchise.
A new report warns that insufficient biosimilar development could result in billions of dollars in lost savings for healthcare systems worldwide.
Meant Health expands telehealth access to FDA-approved GLP-1 prescriptions including Ozempic, broadening patient access to weight-loss medications.
Weekly roundup: Novartis faces multiple clinical setbacks while Anthropic seeks a pharma dealmaker; plus other notable industry developments.
Yarrow Bioscience secures additional funding; AbbVie's Qulipta succeeds in menstrual migraine trial, expanding its potential market.
Alzheon outlines plans for major fundraising round despite Phase 3 miss for Alzheimer's drug — latest biopharma news.
Disc Medicine presents a competitive challenge in polycythemia vera, but Silence Therapeutics maintains its lead in the space.
FDA delays its approval decision for the Exelixis-Tecentriq combination therapy in colorectal cancer, extending the review period.
FDA suggests regulatory flexibility for assessing psychedelics — latest biopharma news.
Frazier Healthcare Partners adds over $1.1 billion to its fund targeting small and mid-sized biotech companies.
Have Moderna, Merck kicked off a 'personalized med revolution'? — latest biotechnology news.
Husqvarna Group first to receive FCC Conditional approval for foreign-manufactured advanced robotic lawn mowers in the U.S. — latest FDA regulatory news.
Longtime Takeda R&D chief to depart next June—Chutes & Ladders — latest biotechnology news.
Medicaid will allow states to use a tiered system to determine medical frailty, affecting work requirement exemptions for beneficiaries.
Mikhail, Davis embody the FDA’s stabilization, Seehafer signals AI revolution is coming — latest biotech and pharma news.
New FDA oncology chief sets priorities in first interview — latest pharmaceutical industry news.
Novartis’ board faces investor scrutiny after M&A misfires and R&D flops — latest biotech and pharma news.
Novartis drags peers down with triple asset stumble — latest biotech and pharma news.
PerZeption receives an NEI Phase 1 SBIR grant to advance its age-related macular degeneration study.
Samsung Biologics inks $262M manufacturing deal with European pharma company — latest biotech and pharma news.
Scientists begin boycott of American Diabetes Association — latest biotechnology news.
Singapore launches biotech-focused Boston hub with glitzy event — latest biotechnology news.
Takeda, Daiichi, Samsung Bio and more—Fierce Pharma Asia — latest pharmaceutical industry news.
Takeda's R&D chief Andy Plump to retire; Novo Nordisk appoints global research head — latest biopharma news.
The future of RAS inhibitors — latest biotechnology news.
U.S. health officials declare an end to a record-setting cyclospora outbreak, though the origin of the parasitic infection remains unknown.
AbbVie eyes Qulipta expansion after menstrual migraine win
AbbVie eyes Qulipta expansion after menstrual migraine win — latest pharmaceutical industry news.
AdJane unveils a mucosal booster strategy for next-generation respiratory vaccine franchises using its nOMV platform technology.
August biopharma layoffs impact just over 500, down 90% year over year
Biohaven epilepsy drug suffers FDA hold days after $350M deal — latest biotechnology news.
Biohaven takes another hit as FDA pauses enrollment in pivotal trials for embattled epilepsy drug
BioMarin dishes ph. 3 results as Voxzogo expansion push underway
BridgeBio Oncology slides as it tightens the scope of its KRAS program
Consano Bio Announces Peer-Reviewed Publication Supporting the Therapeutic Potential of C-1101 in Chronic, Painful Lumbosacral Radiculopathy (LSR) or Chronic Sciatica — latest FDA regulatory news.
Drugmakers cherry pick launch regions as MFN creates 'policy environment like an earthquake'
Encoded raises $275M series F for Dravet syndrome gene therapy
FDA christens Hyrnuo a first-line option for rare lung cancer
FDA places partial hold on Biohaven's ion channel drug
Fluence Selected by Compass Pathways to Develop Post-Approval COMP360 Provider Training — latest FDA regulatory news.
Frazier Life Sciences nets $1.1B in long-running biotech fund
Hikma advances its epinephrine nasal spray with multi-market regulatory filings — latest FDA regulatory news.
How past Endpoints 11 winners fared as the biotech industry rebounded
Lonza invests in US plant; CordenPharma scales injectables — latest pharmaceutical industry news.
Lonza to build new US factory; Samsung Bio signs $262M contract
Mass. governor acknowledges biotech capital 'harder to come by'
NICE rebuffs Gilead's twice-yearly PrEP option
NICE rebuffs Gilead's twice-yearly PrEP option — latest pharmaceutical industry news.
Novartis investor calls for board overhaul after costly setbacks
Novartis investor calls for board overhaul after costly setbacks — latest pharmaceutical industry news.
ObvioHealth and SPRIM PRO Launch Integrated Digital Patient Monitoring and Clinical Support Solution for High-Risk Therapies — latest FDA regulatory news.
Platinum-based chemotherapy in childhood causes mutations that age the liver — latest health and medicine news.
Renova Pharmaceuticals Announces First Three U.S. Generic Product Launches, Marking a Major Company Milestone — latest FDA regulatory news.
Samsung Bio nets $262M manufacturing deal with unnamed pharma
Samsung Bio nets $262M manufacturing deal with unnamed pharma — latest pharmaceutical industry news.
Sanofi serves up pickleball partnership in Nuvaxovid push — latest pharmaceutical industry news.
Seismic Pharmaceuticals Announces the Enrollment of the First Patient in the Global Phase 3 Trial of Istaroxime in Cardiogenic Shock — latest FDA regulatory news.
Shionogi's stroke drug fails mid-stage; Bayer's Hyrnuo gets expanded label in NSCLC
Takeda's long-serving R&D chief Andy Plump to retire
Takeda’s long-term R&D head announces exit after major pipeline reorganization — latest biotech and pharma news.
The blueprint for clinical AI
The supply chain fault lines of modern pharma
Trump officials say AI will help save rural health care. Some leaders in the field don't believe it
Tyra shares slip as bladder cancer responses fall short of investor expectations
Why two promising heart drugs flopped and what’s next — latest health and medicine news.
Eleven biopharma companies are actively hiring in California, offering opportunities across research, development, and commercial roles.
News from BioSpace: A career setback is a data point, not a verdict
Acting CBER, CDER heads become permanent as FDA works to restore stability
News from STAT News: AMA CEO: AI won’t replace doctors — it will work alongside them
News from Endpoints News: ARPA-H selects companies to build AI tools for heart disease
ARPA-H Selects UpDoc to Lead Development of Autonomous Clinical AI System, in an Initiative Joined by Microsoft, OpenAI and NVIDIA
News from STAT News: Autonomous AI will beat AI-assisted physicians at some medical tasks by 2030
Beyond China: Five other overseas destinations for biopharma dollars
News from Fierce Pharma: BioMarin dishes ph. 3 results as Voxzogo expansion push underway
News from BioSpace: BMS clinches pivotal win for myeloma CAR T in ‘key derisking event’
Cancer biotech TwoStep gets $62.5M to take twist on ADCs into clinic
News from Fierce Pharma: Caris lassos Kevin Costner for new Caris Detect ad
Caspian launches with $50M, Lilly support to advance disease-modifying diabetes bet
News from PR Newswire FDA: Cionic Real-World Evidence Study Examines Quality of Life Across Upper Motor Neuron Conditions
News from Endpoints News: Compass posts positive psilocybin data; Solstice makes $225M debut
Coroner releases details of infants who died amid growing Pennsylvania measles outbreak
News from PR Newswire FDA: CraniUS Therapeutics Receives FDA 510(k) Clearance for the CraniUS® Plate, a Patient-Specific Cranial Implant
News from PR Newswire FDA: CS Analytical and Lighthouse Instruments to Host Webinar on USP <382> Testing for Elastomeric Components and Systems
News from Endpoints News: Current heads of CBER, CDER snag permanent jobs
Emboline Receives U.S. FDA 510(k) Clearance for Emboliner® Embolic Protection System
Emboline Receives U.S. FDA 510(k) Clearance for Emboliner® Embolic Protection System — latest FDA regulatory news.
News from Endpoints News: Encoded closes $275M Series F for Dravet syndrome drug
Encoded executes $275M series F to advance Dravet drug
News from Fierce Biotech: Evommune gives up on dermatitis drug after another ph. 2 fail
News from Endpoints News: Expanding its biopharma plans, Anthropic looks for a life sciences dealmaker
News from Endpoints News: FDA should follow EMA's lead on drug rejection disclosures, researchers say
FDA solidifies leadership posts at CDER, CBER
Kura creates Lilly-backed spinout in next-gen diabetes play
News from Endpoints News: Kura Oncology spins out diabetes pipeline with $50M and Lilly's help
News from Fierce Biotech: Luma locks down 15-year, $410M life sciences fund
News from PR Newswire FDA: LUMA Vision Secures FDA Clearance Advancing Procedural Intelligence as the Foundation of the Cardiac Lab of the Future
News from Fierce Pharma: Merck to lay off another 54 at New Jersey HQ
News from PR Newswire FDA: Nanoscope Therapeutics Announces U.S. Food and Drug Administration Acceptance of Biologics License Application for MOGENRY for the Treatment of Retini
News from Endpoints News: NodThera, a decade-old NLRP3 player, plans Phase 3 and a rebrand
News from BioSpace: Novo’s canned heart disease trials, Novartis’ clinical fails, first approval for Alexander disease
nPhase launches AI data platform to improve sponsor trial design
Pharma investment in UK picks up after last year’s lull, trade group says — latest biopharma news.
Sandoz plans ‘vast and vertically integrated’ supply chain to support 100-biosimilar vision
News from Fierce Biotech: Schrödinger births new immunology focused biotech, Tectora
News from BioSpace: Solstice rises with $225M to develop next-gen CTLA-4 drug from China
News from BioSpace: Steady stream of crossover rounds stock biotech’s IPO pipeline
News from Fierce Biotech: Tyra rolls toward pivotal cancer study even as stock deflates
News from PR Newswire FDA: UCB receives U.S. FDA Breakthrough Therapy Designation for CIMZIA®(certolizumab pegol) in pregnant women with antiphospholipid syndrome (APS)
A breakthrough pancreatic cancer drug won approval. They still struggle to access it
Abbott receives FDA approval for its TactiFlex™ Duo Ablation Catheter to treat people with abnormal heart rhythms
Alebund Pharmaceuticals Announces FDA Clearance of IND Application for AP308 for the Treatment of IgA Nephropathy
Amgen’s Imdelltra scores overall survival win in first-line SCLC
News from Endpoints News: Amgen’s lung cancer treatment Imdelltra notches new major victory
AstraZeneca’s SERD pill overcomes adcomm defeat to win FDA nod in breast cancer
AZ's 'science success story' with tozorakimab plays out in full
BrainChild Bio targets deadly pediatric brain cancer with $116M series A
Brainomix and Endeavor BioMedicines Present Positive Results from Quantitative Image Analysis of Phase 2a Idiopathic Pulmonary Fibrosis (IPF) Trial at ERS Congress
News from BioSpace: Can Benelux turn scientific strength into larger biotech scale?
Clinical Science Update | New Clinical Evidence for ClotChek™
News from PR Newswire FDA: FDA Advisory Panel Backs BPC-157 for 503A Bulks List in 8-6-1 Vote, Promise Analysis Finds
FDA's surprise approval of AZ's oral SERD sets new paradigm
Hospitals pursue deals to ensure survival as Trump’s Medicaid cuts loom
Inhibrx says OX40 agonist’s durability confirmed by ph. 2 win
Inhibrx’s OX40 agonist add-on beats Keytruda alone in head and neck cancer
News from STAT News: It’s time to take the gloves off during vaccination
Moderna and Merck’s mRNA success fuels focus on ‘scaling out and scaling down’
Moonwalk pulls in $70M to take fat-targeting RNAi obesity candidate to clinic
Novartis’ $12B Avidity acquisition hits Phase 3 speedbump as dystrophy drug disappoints
Novartis’ cholesterol-lowering medicine fails Phase 3, clouding Lp(a) horizons
Novo shutters 2 more heart disease studies, indicating IL-6 is ‘invalid target’
News from Endpoints News: Pharvaris' stock jumps on pivotal success in rare genetic disease
Reeling from past failures, Parkinson’s pipeline enters ‘era of diversification’
News from STAT News: Reynolds is selling fruity new vapes unauthorized by FDA
Roche sweeps neurology corporate reputation rankings once again
Roivant’s $14M bet on Bayer’s inhaled hypertension med pays off
Roivant’s pulmonary hypertension drug shines with ‘blowout’ Phase 2 data — latest biotech and pharma news.
Sandoz sets ambitious goal to grow biosimilar bona fides by 2040
Sanofi tags in new Beyfortus spokesperson in actress Keke Palmer
Spyre 3-pronged IBD strategy on track with IL-23 drug ph. 2 win
Structure’s obesity portfolio impresses on GLP-1 and amylin fronts in dual data drop
Wegovy helps free 40% of kids from obesity in phase 3 trial
News from Endpoints News: BrainChild Bio gets $116M for pivotal trial of pediatric brain tumor CAR-T
A new blood pressure monitor from CART demonstrates clinical utility for monitoring patients with atrial fibrillation and heart failure.
Venture capital firm Claret announces its latest fund will expand its focus on European life sciences investments.
News from Endpoints News: FDA approves AstraZeneca’s oral SERD for breast cancer despite negative adcomm vote
News from Endpoints News: Inhibrx opens door to cancer vaccine combo for its OX40 agonist
News from Endpoints News: Moonwalk raises $70M to test siRNA treatment for obesity
Novartis' Phase 3 pelacarsen study miss in cardiovascular disease raises competitive stakes for Amgen and Eli Lilly in the space.
Novo Nordisk's blockbuster hopes for its chronic kidney disease program dwindle after additional Phase 3 trials are scrapped.
News from Endpoints News: Sandoz unveils plan for biosimilar expansion and new $300M factory in Slovenia
AbbVie-backed ADARx Pharmaceuticals plans an IPO to fund its clinical-stage siRNA therapy pipeline.
AstraZeneca launches a new AI-generated ad campaign featuring a llama to promote its Breztri combination inhaler for COPD.
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