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906 stories matching this filter · ← front page

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  • US biotech firms grow more secretive amid rising competition from Chinese industry
    US biotech companies are becoming more secretive as competition from China’s rapidly expanding biotech sector intensifies. Janine Sengstack, a senior scientist at Junevity, says her team may have…
    Endpoints · 1mo agoNegative↗ source
  • German parliament approves cost-cutting health bill, pharma industry warns of exit risk
    German federal parliament voted to pass a bill aimed at reducing domestic healthcare expenditures. The legislation seeks to curb spending on medicines and other health services as part of a broade…
    Endpoints · 1mo agoRegulatoryNegative↗ source
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  • Hansoh reports Phase 3 success for GSK‑partnered ADC in SCLC as FDA clears Sanofi on‑body injector
    Hansoh announced that its Phase 3 trial of the antibody‑drug conjugate Ris‑Rez met the primary endpoint in patients with small cell lung cancer. The study was conducted in partnership with GSK and…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networks
    The FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
    fda press · 1mo agoRegulatoryPositive↗ source
  • Apnimed announces IPO plans while FDA reviews its sleep-apnea therapy
    Apnimed, a Cambridge, Massachusetts biotech, disclosed that it will pursue an initial public offering on Nasdaq. The move comes as the company’s lead sleep‑apnea candidate is under review by the U…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA resumes publishing pharma rejection letters, posting 14 new CRLs
    The FDA announced on Friday that it has posted fourteen new complete response letters (CRLs) to pharmaceutical companies on its website. This marks a return to the agency’s regular practice of mak…
    Endpoints · 1mo agoCRLNeutral↗ source
  • Pfizer promotes Danna Breen to lead obesity discovery, succeeding Kendra Bence
    Pfizer announced that Danna Breen has been promoted to head of its obesity discovery program, according to a LinkedIn post. Breen takes over from Kendra Bence and brings nearly 14 years of experie…
    Endpoints · 1mo agoNeutral↗ source
  • FDA’s drug review center adds over 100 staff in a quarter, first net gain since late 2024
    The FDA’s Center for Drug Evaluation and Research (CDER) reported hiring more than 100 new employees in the most recent quarter. This net increase is the first time the drug center has added more…
    Endpoints · 1mo agoNeutral↗ source
  • Cellular Intelligence hires neurologist to assess Novo Nordisk's Parkinson's stem cell program
    Cellular Intelligence, an AI‑driven biotech, announced it is evaluating Novo Nordisk's Parkinson's stem cell therapy after Novo shut down its cell therapy unit. The company engaged neurologist and…
    Endpoints · 1mo agoDealNeutral↗ source
  • ARPA-H earmarks $160 million for custom gene-editing therapies, sparking debate on adequacy
    ARPA-H announced a $160 million investment to support development of bespoke gene‑editing treatments. This follows a recent case where an infant was rescued from a lethal disease using a personaliz…
    Endpoints · 1mo agoNeutral↗ source
  • HHS proposes new rule to compensate Covid-19 vaccine injury claims
    The U.S. Department of Health and Human Services has issued a proposed rule that would create a compensation mechanism for people who say they were injured by Covid-19 vaccines. The new system is…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Roche halts development of Huntington’s disease drug tominersen after ten years of trials
    Roche announced it is stopping work on tominersen, its experimental therapy for Huntington’s disease. The decision follows a Phase 2 study in which the drug performed no better than placebo. The c…
    Endpoints · 1mo agoNegative↗ source
  • UK regulator advises stopping reimbursement for Amgen's lung cancer drug Lumakras for new patients
    The National Institute for Health and Care Excellence (NICE) in the United Kingdom released draft guidance recommending that government reimbursement for Amgen’s lung cancer therapy Lumakras be dis…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA reprimands Lundbeck Seattle Biopharmaceuticals for inflated claims on Vyepti migraine webpages
    The U.S. Food and Drug Administration issued an untitled letter to Lundbeck Seattle Biopharmaceuticals criticizing two promotional webpages about its migraine treatment Vyepti. The agency said the…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA pauses public release of Complete Response Letters to limit litigation risk
    The FDA announced it has temporarily halted the routine public posting of Complete Response Letters (CRLs), which are letters sent to drug sponsors when the agency does not approve a marketing appl…
    Endpoints · 1mo agoCRLNeutral↗ source
  • The biggest health tech stories of 2026 — so far
    We’re more than halfway through 2026, and it’s been an eventful year. Here are the five biggest developments we noticed in the first six months. Major AI companies are coming for healthcare.
    Endpoints · 1mo ago↗ source
  • Ipsen succeeds in migraine trials; Tarsus buys iRenix for $75M upfront
    Plus news on Alchemab, Scipher and Forte. 💉 Ipsen’s Dysport aces Phase 3 migraine trials: The biotech’s injectable neurotoxin met the primary endpoint of reducing monthly migraine days in two ...
    Endpoints · 1mo ago↗ source
  • Eli Lilly dominates first-half biotech acquisitions, with no sign of slowing down
    Riding on its trillion-dollar heft and successes in treating obesity, Eli Lilly has now become a force in one area where it hasn’t historically been the main player: M&A. The Indianapolis-based dru…
    Endpoints · 1mo ago↗ source
  • Catalent to divest UK site; Rottendorf, Evonik announce manufacturing builds
    Plus, news about RoslinCT, Novo Nordisk and more. 🇬🇧 Catalent to sell UK site to Codis: The CDMO is set to take Catalent’s oral solid dose factory in Nottingham, with ...
    Endpoints · 1mo ago↗ source
  • GSK walks away from Alector pact as immuno-neurology bet fizzles
    After two high-profile trial failures over the past year, GSK is breaking off a deal that features $700 million upfront that it signed with Alector for neurodegenerative disease treatments. GSK’s e…
    Endpoints · 1mo ago↗ source
  • Updated: AstraZeneca sinks on unexpected heart drug trial failure
    AstraZeneca’s shares dropped in early trading Thursday after a heart disease treatment it is developing with Ionis Pharmaceuticals surprisingly failed in a late-stage trial. The companies had aimed…
    Endpoints · 1mo ago↗ source
  • Early Alert: Convenience Kit Issue from Medical Action Industries
    Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
    fda medwatch · 1mo ago↗ source
  • Early Alert: Convenience Kits Issue from Medline
    Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
    fda medwatch · 1mo ago↗ source
  • Prime Medicine wins spat with Beam Therapeutics over AATD candidate
    Prime Medicine is headed for the clinic after winning a dispute with Beam Therapeutics, another gene editing biotech with roots in the same lab. Arbitrators determined that a 2019 contract between…
    Endpoints · 1mo ago↗ source
  • HHS lays groundwork for new FDA rule on releasing CRLs
    The Trump administration is pushing the FDA to cement the details behind its proactive public release of rejection letters sent to pharma companies. The push comes as an HHS spokesperson confirmed…
    Endpoints · 1mo ago↗ source