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674 stories matching this filter · ← front page

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  • Moderna and Merck’s individualized cancer vaccine shows promising melanoma results but shares tumble after ESMO presentation
    Investors closely watched the European Society for Medical Oncology (ESMO) meeting for updates on an individualized neoantigen cancer vaccine being co‑developed by Moderna and Merck. The therapy, c…
    BioPharma Dive · 9d agoPositive readoutNeutral↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 9d agoEarningsPositive↗ source
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globenewswire health73
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Psychiatry & CNS1162
Ophthalmology984
Endocrinology & Metabolism768
Pain766
Nephrology735
  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 9d agoDealPositive↗ source
  • Instrumentation Laboratories recalls several lots of HemosIL AcuStar HIT-IgG(PF4-H) assay due to false-negative risk
    Instrumentation Laboratories (Werfen) has issued a recall of specific lots of its HemosIL AcuStar HIT-IgG(PF4-H) radioimmunoassay after the FDA identified a performance issue that could produce fal…
    fda medwatch · 10d agoCRLNegative↗ source
  • Aspen Neuroscience raises $140M IPO to advance Parkinson’s cell therapy
    Aspen Neuroscience, a San Diego biotechnology company, completed an initial public offering, selling roughly 9.4 million shares at $15 each and raising about $140.6 million. The capital will be di…
    BioPharma Dive · 10d agoDealPositive↗ source
  • Nova Biomedical issues safety instructions for StatStrip Glucose Hospital Meter Gen 2.0
    Nova Biomedical has sent a letter to customers using the StatStrip Glucose Hospital Meter System Gen 2.0, advising updated use instructions while a software fix is prepared. The FDA classified the…
    fda medwatch · 10d agoCRLNegative↗ source
  • Genmab shares jump as petosemtamab plus Keytruda halves death risk in head-neck cancer trial
    Genmab reported that a late-stage study of its experimental antibody petosemtamab combined with Keytruda cut the risk of death by about 50 percent compared with Keytruda alone in patients with PD‑L…
    BioPharma Dive · 10d agoPositive readoutPositive↗ source
  • Labor Dept finalizes PBM disclosure rule to boost transparency for self-insured employers
    The U.S. Labor Department has finalized a rule that will require pharmacy benefit managers to disclose detailed fee and compensation information to self-insured employer clients, with the requireme…
    BioPharma Dive · 10d agoRegulatoryNeutral↗ source
  • Flagship Pioneering merges three biotech startups to launch AI-driven drugmaker Etcelera
    Flagship Pioneering announced the creation of Etcelera Therapeutics by merging three of its portfolio companies - Etiome, Cellarity and Empress Therapeutics. The new venture will combine artificia…
    BioPharma Dive · 10d agoDealPositive↗ source
  • Medline orders removal of all brand beds and accessories over fire and asphyxiation hazards
    Medline has issued an urgent field safety notice indicating that all of its branded hospital beds and related components must be removed or corrected because of identified safety risks. The FDA’s…
    fda medwatch · 11d agoRegulatoryNegative↗ source
  • HHS to allow compounders to make 6 unapproved peptides
    RFK Jr. has given notice that the agency won’t take enforcement action on six peptides that controversially won a contested recommendation from outside advisers to the FDA in July.
    BioPharma Dive · 10d ago↗ source
  • FDA releases draft guidance to streamline approval of personalized gene therapies
    The FDA announced a draft guidance aimed at expanding access to gene therapies that target different mutations within the same disease. The proposal outlines an "individualized feature space" that…
    BioPharma Dive · 11d agoRegulatoryPositive↗ source
  • Eli Lilly to merge U.S. and international units after exec retirement; Novartis records $1.9B impairment on failed Avidity drug
    Eli Lilly announced that its U.S. and international divisions will be combined into a single unit called "Lilly Global Markets" after the retirement of long‑time executive Patrik Jonsson at the end…
    BioPharma Dive · 11d agoNeutral↗ source
  • Lilly’s ‘triple-G’ drug tops Novo’s Ozempic in diabetes trial
    The highest dose of retatrutide beat Ozempic on measures of blood sugar and weight loss, but was also associated with higher side effect rates and treatment discontinuations.
    BioPharma Dive · 11d ago↗ source
  • Federal judge denies Novo's attempt to block Eli Lilly obesity drug ads
    A federal judge in the U.S. District Court denied Novo Nordisk's request to halt an Eli Lilly advertising campaign that compared the two companies' obesity treatments, Wegovy and Zepbound. Novo ar…
    BioPharma Dive · 12d agoRegulatoryNeutral↗ source
  • FDA issues early alert on B. Braun Streamline Bloodline Set recall due to connector leak risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert about B. Braun's Streamline Bloodline Set for Dialog+ after discovering a potential high risk issue. The problem is trace…
    fda medwatch · 13d agoCRLNegative↗ source
  • Ferring to acquire next-gen IVF startup Gameto for up to $1.4B
    The buyout hands Ferring rights to a technology capable of simplifying the lengthy and burdensome process of in vitro fertilization.
    BioPharma Dive · 12d ago↗ source
  • Artiva to quit autoimmune cell therapy work, cut staff after patient deaths
    The disclosure makes Artiva the third company to recently report fatal events in an autoimmune cell therapy trial, following announcements from Novartis and Bristol Myers Squibb.
    BioPharma Dive · 12d ago↗ source
  • Melanoma vaccine shows 42% risk reduction at ESMO 2026, but shares tumble on early data release
    Moderna and Merck presented Phase 3 results for their melanoma vaccine intismeran autogene at the European Society for Medical Oncology meeting. The trial reported a 42% reduction in the relative r…
    BioPharma Dive · 13d agoPositive readoutNeutral↗ source
  • Corxel to go public via $300 million SPAC merger, advancing GLP-1 pill CX11 and amylin candidate
    Corxel Pharmaceuticals announced it will become a public company by merging with the SPAC Amanat Acquisition Corp., accompanied by a $300 million private investment. The transaction will fund the…
    BioPharma Dive · 13d agoDealPositive↗ source
  • Patient dies after receiving Bristol Myers experimental autoimmune CAR-T therapy zola-cel
    A participant in Bristol Myers Squibb’s multiple sclerosis trial died 44 days after being infused with the experimental cell therapy known as zola-cel. The company disclosed that the patient develo…
    BioPharma Dive · 13d agoNegative readoutNegative↗ source
  • Overlooked drugs can gain value when markets evolve, says Azurity CEO
    Ron Scarboro, chief executive of Azurity Pharmaceuticals, wrote about how medicines that seemed unsuccessful can become valuable when market conditions change. He argues that the industry often co…
    BioPharma Dive · 14d agoNeutral↗ source
  • Manufacturing hurdles grow as next-gen protein therapeutics gain traction
    Cytiva's sponsored piece highlights growing interest in next-generation protein-based drugs such as antibody-drug conjugates, multispecific antibodies, fragments and synthetic peptides. These moda…
    BioPharma Dive · 14d agoNeutral↗ source
  • BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study
    The companies said the findings suggest the treatment has a “limited” impact in HER2-low breast cancer, an area where AstraZeneca and Daiichi Sankyo’s Enhertu has already set a high bar.
    BioPharma Dive · 13d ago↗ source
  • Lycia Therapeutics raises $318 million in IPO to fund protein degrader programs
    Lycia Therapeutics, a biotech focused on protein-degrading medicines, priced its initial public offering at about $318 million. The proceeds will be used to advance three LYTAC drug candidates, in…
    BioPharma Dive · 17d agoDealPositive↗ source