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1,868 stories matching this filter · ← front page

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  • FDA’s fast-track voucher program appears to be discontinued, report finds
    A recent report indicates that the FDA’s expedited voucher program, launched to speed approval of certain drugs, has not issued any new vouchers in the six months since former commissioner Marty Ma…
    Endpoints · 5h agoRegulatoryNegative↗ source
  • Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
    Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
    fda recalls · 8h agoCRLNegative↗ source
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  • EnGene reports improved bladder cancer data after May setback
    EnGene, a biotech developing a bladder cancer therapy, released new data that appear more encouraging than the results disclosed in May. The May data had shown limited durability, causing a sharp…
    Endpoints · 8h agoPositive readoutPositive↗ source
  • BioNTech spends $205 million to buy Scholar Rock’s FDA priority-review voucher as J&J scales back in Norway
    BioNTech announced it has purchased an FDA priority review voucher from Scholar Rock for $205 million. The voucher, which can be used to accelerate the regulatory review of a future drug, was origi…
    Endpoints · 9h agoDealPositive↗ source
  • Merck KGaA records €366 million impairment on Lonza CDMO sale as PharmaLogic acquires Lantheus' manufacturing unit
    Merck KGaA disclosed a €366 million ($405.8 million) impairment loss tied to the sale of its contract development and manufacturing organization (CDMO) business to Lonza, according to its third‑qua…
    Endpoints · 9h agoDealNegative↗ source
  • Parker Institute chief urges renewed focus on cancer immunotherapy after mixed results from Revolution Medicines' drug
    Ira Mellman, who leads research at the Parker Institute for Cancer Immunotherapy, said on Sept. 16, 2026 that he felt disappointment and frustration as the industry celebrated Revolution Medicines'…
    Endpoints · 11h agoNegative↗ source
  • Blackstone pledges up to $1.5 billion to fund Pfizer's obesity drug berobenatide development
    Blackstone Life Sciences has agreed to provide up to $1.5 billion to support the research and development of Pfizer's obesity candidate, berobenatide, which originated from the former Metsera progr…
    Endpoints · 13h agoDealPositive↗ source
  • FDA pauses voucher program as Eli Lilly's GLP-1 weight-loss drug cleared in China; experts see AI aid for device regulation
    The U.S. Food and Drug Administration announced it is shelving the commissioner's voucher program, effectively pausing the incentive that speeds up review of certain products. Eli Lilly secured ap…
    raps · 1d agoRegulatoryNeutral↗ source
  • EMA seeks industry input on draft guideline for biomarker-guided therapy approvals
    The European Medicines Agency has published a draft guideline that details the information required for approving medicines that use biomarkers to select patients. The agency is opening a public c…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA asks industry for feedback on improving patient-level real-world data submissions
    The FDA announced a request for comments on ways to address challenges associated with submitting patient-level real-world data and evidence in drug and biologic applications. The agency is seekin…
    raps · 1d agoRegulatoryNeutral↗ source
  • Google launches Gemini AI platform for healthcare
    Google has introduced Gemini, a new artificial‑intelligence platform aimed at the healthcare sector. The rollout marks the company's latest move into health‑focused technology. The firm already su…
    Endpoints · 5h agoPositive↗ source
  • HHS rolls out new funding and research programs for psychedelics, with a focus on ibogaine
    HHS announced Thursday a series of new funding allocations and research initiatives aimed at advancing the study of psychedelic compounds. The effort follows President Donald Trump's spring execut…
    Endpoints · 4h agoRegulatoryPositive↗ source
  • Rezera delays $200M IPO amid weak market conditions
    Rezera, a biotech developing drugs for cardiovascular and inflammatory diseases, announced that it will not proceed with its planned initial public offering that had been scheduled for Friday. The…
    Endpoints · 5h agoDealNegative↗ source
  • Game Changer Products recalls 10 Day Forecast capsules after FDA finds undeclared sildenafil and acetaminophen
    Game Changer Products LLC announced a voluntary nationwide recall of its 10 Day Forecast capsules, a dietary supplement marketed at 3200 mg. The FDA’s analysis detected the presence of undeclared…
    fda recalls · 8h agoCRLNegative↗ source
  • Bristol Myers shifts R&D leadership to chief medical officer Cristian Massacesi as research head Robert Plenge departs
    Bristol Myers Squibb announced a reorganization of its research and development structure. The company said chief medical officer and head of development Cristian Massacesi will assume the duties…
    Endpoints · 12h agoNeutral↗ source
  • Specialized AI tools could streamline medical device regulatory work, experts say, but need expert oversight
    At a recent RAPS AI in Regulatory conference in Barcelona, a panel of experts discussed the role of specialized artificial intelligence in meeting regulatory requirements for medical devices. They…
    raps · 1d agoRegulatoryNeutral↗ source
  • Flagship Pioneering combines Valo Health and Montai Therapeutics into a single company
    Flagship Pioneering announced that two of its portfolio companies, Valo Health and Montai Therapeutics, are merging to form a new entity. The combined firm will consolidate resources and expertise…
    Endpoints · 1d agoDealNeutral↗ source
  • Beeline Medicines reports promising Phase 2 results for lupus using repurposed Bristol Myers drug
    Beeline Medicines announced that its Phase 2 trial in systemic lupus erythematosus produced encouraging results. The study tested three different doses of a compound originally discovered by Brist…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • VectorY Therapeutics raises $83.5M Series A to develop brain-targeted antibody gene therapy
    VectorY Therapeutics announced it has closed a Series A financing round, adding €74.5 million ($83.5 million) to its capital. The funds will be used to advance its lead gene-therapy candidate VTx-…
    Endpoints · 1d agoDealNeutral↗ source
  • Neurosterix raises $105 million Series B to advance schizophrenia candidate
    Neurosterix announced it has closed a $105 million Series B financing round. The capital will be used to develop its lead drug candidate for schizophrenia, which targets a pathway also addressed by…
    Endpoints · 1d agoDealPositive↗ source
  • Merck KGaA receives FDA approval for Abbisko-licensed joint tumor therapy
    Merck KGaA announced that the U.S. Food and Drug Administration has granted approval to a drug it licensed from Chinese biotech Abbisko. The approval covers treatment of rare non-cancerous tumors t…
    Endpoints · 1d agoApprovalPositive↗ source
  • FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapies
    The U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors. The g…
    raps · 2d agoRegulatoryNeutral↗ source
  • UK science minister urges life-science firms to boost domestic investment as government raises medicine spending
    At a Financial Times Global Pharma and Biotech Summit, the UK science minister highlighted the need for greater domestic investment in life-science companies. The call follows a recent increase in…
    Endpoints · 1d agoPositive↗ source
  • Hims & Hers pivots to branded GLP-1 drugs after striking deal with Eli Lilly
    Hims & Hers, which previously emphasized personalized care through compounded products, is changing its business model. The company is now focusing on established brand-name GLP-1 treatments rathe…
    Endpoints · 1d agoDealPositive↗ source
  • Bayer's asundexian receives FDA approval for stroke prevention
    Bayer announced that the U.S. Food and Drug Administration has approved its oral anticoagulant asundexian for stroke prevention. The drug is indicated to lower the risk of subsequent stroke in pati…
    Endpoints · 3d agoApprovalPositive↗ source