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3,010 stories matching this filter · ← front page

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  • FDA issues revised draft guidance for drug-device combination product performance
    The U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characte…
    raps · 12d agoRegulatoryNeutral↗ source
  • Eli Lilly consolidates US and international sales under new global markets unit as veteran exec retires
    Eli Lilly announced that long‑time executive Patrik Jonsson will retire after 36 years with the company. Jonsson has been serving as executive vice president and president of Lilly International, o…
    Fierce Biotech · 12d agoNeutral↗ source
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  • Biopharma job postings in New York surge 109% year over year, eight firms hiring
    BioSpace data shows that biopharma job postings in New York have surged, rising 109% from Oct 1 2025 to Oct 26 2026, with month‑over‑month gains of 32% in August‑September and 19% in September‑Octo…
    BioSpace · 12d agoPositive↗ source
  • Lilly can’t stop, won’t stop as revenue climbs 39% thanks to GLP-1 bestsellers
    Eli Lilly’s shares rose 4% in early morning trading after reporting revenue of $24.4 billion, well past consensus estimates.
    BioSpace · 12d agoEarningsNeutral↗ source
  • HHS adopts enforcement discretion allowing compounding pharmacies to produce six unapproved peptides
    HHS announced an "enforcement discretion" policy that permits compounding pharmacies to make six peptide products that have not received FDA approval. The list includes BPC-157 and TB-500, which a…
    BioSpace · 12d agoRegulatoryNeutral↗ source
  • Genmab’s bispecific antibody petosemtamab plus Keytruda cuts death risk by half in Phase 3 head‑and‑neck cancer trial
    Genmab announced that its bispecific antibody petosemtamab, combined with Merck’s Keytruda, met both co‑primary endpoints in a Phase 3 trial for head‑and‑neck squamous cell carcinoma. The LiGeR‑HN…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • Genmab's bispecific combo with Keytruda halves death risk in phase 3 head‑neck cancer trial
    Genmab announced interim results from its phase 3 LiGeR-HN1 study, showing that adding the bispecific antibody petosemtamab to Merck's Keytruda significantly improved outcomes for patients with PD-…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • Lilly's retatrutide outperforms Ozempic in phase 3 trial, cutting blood sugar and weight more
    Eli Lilly tested its triple-G candidate retatrutide against Novo Nordisk's Ozempic (semaglutide) in an open-label phase 3 study involving about 1,300 adults with type 2 diabetes whose glucose was n…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • Big pharma holds $188 bn for M&A, J&J seen as most likely buyer, analysis shows
    The latest Leerink Partners analysis finds that the largest pharmaceutical companies collectively have about $188 billion in cash available for mergers and acquisitions. All but one of the firms su…
    BioSpace · 13d agoDealPositive↗ source
  • FDA issues draft guidance to streamline approval of personalized gene therapies and expands CMS access model
    The Food and Drug Administration released a draft guidance that lets a single biologics license application cover multiple variants of a gene‑therapy product. The guidance introduces an Individuali…
    BioSpace · 13d agoRegulatoryPositive↗ source
  • Astellas signs up to $1.34 billion option deal for Audax's DAX-044 immuno-oncology candidate
    Astellas Pharma announced it will pay up to $1.34 billion for an exclusive option to license Audax Biosciences' investigational antibody-cytokine fusion, DAX-044. The agreement includes an undiscl…
    BioSpace · 13d agoDealPositive↗ source
  • Astellas commits up to $285M upfront for Audax's preclinical IL-12 program, with potential $1.05B milestones
    Astellas Pharma has entered a licensing agreement with Audax Biosciences to gain rights to the latter’s IL-12 immuno‑oncology candidate DAX‑044. Under the deal, Astellas will pay up to $285 millio…
    Fierce Biotech · 13d agoDealPositive↗ source
  • Geron halts phase 3 Rytelo trial after data monitoring panel deems unlikely to improve survival in JAK-inhibitor-pretreated myelofibrosis
    Geron announced the discontinuation of its phase 3 IMpactMF trial of Rytelo (imetelstat) in patients with myelofibrosis who had previously failed JAK inhibitor therapy. The decision followed an in…
    Fierce Biotech · 12d agoNegative readoutNegative↗ source
  • FDA outlines pathway for approval of personalized gene-editing therapies
    The U.S. Food and Drug Administration released a set of recommendations describing how developers can pursue regulatory approval for gene-editing treatments that are customized to a single patient’…
    Endpoints · 13d agoRegulatoryNeutral↗ source
  • AstraZeneca’s heart drug Wainua fails late-stage trial, raising 2027 outlook concerns
    AstraZeneca announced that its experimental heart disease therapy, Wainua, did not meet primary endpoints in a Phase III trial conducted in July. The failure is a setback for the company, whose pi…
    Endpoints · 13d agoNegative readoutNegative↗ source
  • Biogen sees continued revenue growth and pipeline readouts, M&A not essential, CEO says
    Biogen reported third‑quarter earnings, marking a third straight quarter of revenue growth driven by its marketed products. The increase stemmed from higher sales of the Alzheimer’s therapy Leqemb…
    BioSpace · 13d agoEarningsPositive↗ source
  • Pfizer shuts India cancer drug plant for up to two years, worsening drug shortages
    Pfizer has temporarily closed a manufacturing site in India that produces several cancer medicines. The company says the facility will remain idle for as long as two years while it addresses the i…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Biogen posts third consecutive quarter of revenue growth, driven by Leqembi, Spinraza and Apellis products
    Biogen reported $2.8 billion in revenue for the third quarter, marking its third straight period of top‑line growth. The company credited its growth portfolio, led by the Alzheimer’s therapy Leqem…
    BioSpace · 13d agoEarningsPositive↗ source
  • Five newly approved drugs achieve strong launches by offering superior efficacy, pricing and access
    Over the past year several newly approved therapies have entered the market with sales and uptake that far exceed analyst expectations, driven by strong clinical data, reasonable pricing and easy p…
    BioSpace · 13d agoPositive↗ source
  • Biotech firms must adopt global regulatory strategies to commercialize drugs independently
    Biotech developers are increasingly able to fund the pursuit of regulatory approval and commercial launch on their own, rather than selling their assets early. This new option is driven by a reboun…
    BioSpace · 13d agoRegulatoryPositive↗ source
  • Formation Bio raises $600 million fund to expand AI-driven drug licensing and testing model
    Formation Bio, an AI-focused biotech that builds value by acquiring external drug assets, developing them and then transferring them to partners, announced a new financing round. The company secur…
    Endpoints · 12d agoDealPositive↗ source
  • Oura and UC San Diego Health launch trial linking smart ring data to obesity treatment outcomes
    Oura and UC San Diego Health have partnered on a multi-year clinical trial called SMART-BMI to explore how continuous data from the Oura Ring may reflect patient response to obesity therapies. The…
    Fierce Biotech · 13d agoPositive↗ source
  • Analysts Question Biogen's Lupus Drug Litifilimab Ahead of Key Phase 3 Readouts
    Analysts pressed Biogen CEO Chris Viehbacher during a recent call, focusing on the company's late‑stage pipeline. The discussion centered on litifilimab, Biogen’s experimental lupus therapy, with…
    Endpoints · 13d agoNeutral↗ source
  • FDA proposes new rare disease framework to accelerate therapy development
    During a public hearing, FDA officials outlined a newly proposed rare disease framework aimed at creating a lasting regulatory scheme. The initiative seeks to speed the development of safe and eff…
    Fierce Biotech · 13d agoRegulatoryPositive↗ source
  • Chinese biotech BioGeometry secures over $100 million Series A for AI-driven protein design
    BioGeometry, a four-year-old biotech startup based in Beijing, announced it has closed a Series A financing round of more than $100 million. The capital will be used to expand its artificial-intel…
    Endpoints · 13d agoDealPositive↗ source