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1,425 stories matching this filter · ← front page

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  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 27d agoRegulatoryNeutral↗ source
  • Becton Dickinson recalls intraosseous needle sets over risk of obturator removal difficulty
    Becton Dickinson has issued a recall for specific intraosseous vascular access system needle sets after discovering that the obturator (stylet) can be difficult to remove once the device is placed.…
    fda medwatch · 27d agoCRLNegative↗ source
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  • Oma's Pride recalls one lot of 6 lb Woof Complete canine chicken food after Salmonella contamination
    Oma's Pride of Avon, Connecticut, announced a voluntary recall of a single lot (BB012729) of its 6‑lb Woof Complete Canine Chicken Recipe pet food after testing revealed Salmonella contamination.…
    fda recalls · 26d agoCRLNeutral↗ source
  • Trump orders MMR vaccine as LSD-targeted drug passes Phase 3 trial
    The latest Endpoints Weekly notes that President Trump placed an order for the measles‑mumps‑rubella (MMR) vaccine. The newsletter also reports that a drug being developed for LSD‑related indicati…
    Endpoints · 29d agoPositive readoutNeutral↗ source
  • EU regulator withdraws Amgen's Tavneos authorization over serious trial breaches
    European regulators have withdrawn the marketing authorization for Amgen's rare disease drug Tavneos, citing serious breaches in the pivotal clinical trial. The EMA said study staff from ChemoCent…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Biotech firm Biogen secures Chinese approval for felzartamab in second-line multiple myeloma
    Biogen announced that its monoclonal antibody felzartamab has received regulatory clearance in China for use in patients with multiple myeloma who have already received first-line therapy. The app…
    Endpoints · 29d agoApprovalPositive↗ source
  • FDA grants accelerated approval to BMS’s iberdomide, branded Zenbexus, as generic competition hits Revlimid and Pomalyst sales
    The FDA has granted accelerated approval to iberdomide, now marketed as Zenbexus, for patients with multiple myeloma who have received at least one prior line of therapy. The drug is to be used in…
    BioSpace · 1mo agoApprovalNeutral↗ source
  • Capricor Therapeutics sees stock surge as FDA signals openness to extend review of DMD cell therapy
    Capricor Therapeutics' CEO Linda Marbán told investors that the FDA is receptive to adding open label extension data to its Biologics License Application for deramiocel, its Duchenne muscular dystr…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Capricor to submit additional data to FDA after negative advisory committee vote on Duchenne therapy
    Capricor Therapeutics announced it will request the FDA to review new data and analyses for its experimental treatment for Duchenne muscular dystrophy. The move follows a recent negative vote from…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Abcuro raises $66 million to launch Phase 3 trial in muscle-weakening disease after earlier setback
    Abcuro announced it has secured $66 million in financing to support a Phase 3 clinical study targeting a muscle-weakening condition. The funding comes after the company previously reported that it…
    Endpoints · 1mo agoDealNeutral↗ source
  • ICER finds AstraZeneca’s blood pressure pill Baxfendy not cost-effective at $10,950 a year
    ICER released a report saying the clinical benefits of AstraZeneca’s new blood pressure medication Baxfendy do not justify its listed price. The agency noted the drug is priced at $10,950 per pati…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Overseas MDMA and psilocybin makers eye U.S. market as regulatory landscape eases
    Companies that produce MDMA and psilocybin for patients abroad are turning their attention to the United States, hoping to leverage experience gained under more permissive foreign rules. Rising pol…
    BioSpace · 1mo agoPositive↗ source
  • Redx Pharma pursues new reverse merger with Skye after 2023 setback
    Redx Pharma, a UK biotech focused on ROCK inhibitor therapies for fibrosis, is seeking a reverse merger with Skye to obtain a Nasdaq listing. The company previously attempted a similar transaction…
    Endpoints · 1mo agoDealNeutral↗ source
  • Bicara appoints President Ryan Cohlhepp as CEO effective Jan. 1, while J&J veteran John Reed joins Madrigal board
    Bicara Therapeutics announced a leadership transition, naming its current President and COO Ryan Cohlhepp as the new chief executive officer effective Jan. 1. Cohlhepp will take over the role as t…
    Endpoints · 1mo agoNeutral↗ source
  • Cytokinetics sues Bristol Myers Squibb over recently granted patent, intensifying rivalry
    Cytokinetics has filed a lawsuit against Bristol Myers Squibb, seeking to invalidate a patent that was recently granted to the latter. The legal action adds a courtroom dimension to an already com…
    Endpoints · 29d agoCRLNegative↗ source
  • MapLight Therapeutics pauses early‑stage programs to focus on lead schizophrenia and Alzheimer’s psychosis candidate
    MapLight Therapeutics announced it is pausing its preclinical and discovery activities. The company said it will redirect resources toward advancing its lead candidate, ML-007C-MA, which is being d…
    Endpoints · 1mo agoNeutral↗ source
  • Exotique Foods recalls Momchipz Veggie Chips for possible undeclared gluten
    Exotique Foods Inc of Ontario announced a recall of its Momchipz Veggie Chips in the broccoli florets and cauliflower flavor because the product may contain undeclared gluten. The chips, sold in 3…
    fda recalls · 29d agoCRLNegative↗ source
  • The Hampton Grocers recalls 8-oz Lacnola Lactation Granola over possible Salmonella contamination
    The company announced a recall of its 8-oz Lacnola Lactation Granola due to potential Salmonella contamination. The product was sold nationwide through the company's website and other online retai…
    fda recalls · 29d agoRegulatoryNeutral↗ source
  • Exotique Foods recalls Momchipz Veggie Chips over undeclared wheat risk
    Exotique Foods Inc announced a recall of its Momchipz Veggie Chips Broccoli Florets & Cauliflower because the product may contain undeclared wheat, posing a serious allergy risk. The chips, sold t…
    fda recalls · 29d agoCRLNegative↗ source
  • FDA grants accelerated approval to Bristol Myers' iberdomide for relapsed or refractory multiple myeloma
    The U.S. Food and Drug Administration has issued an accelerated approval for iberdomide, a small-molecule therapy developed by Bristol Myers Squibb. The approval targets patients with multiple mye…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Taiho and Cullinan’s zipalertinib shows progression‑free survival benefit in Phase 3 NSCLC trial
    Taiho Pharmaceutical and Cullinan Therapeutics reported that their EGFR inhibitor zipalertinib, combined with chemotherapy, significantly extended progression‑free survival for patients with advanc…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • European regulators withdraw Amgen's Tavneos over questionable data
    European regulators announced they are pulling Amgen's rare disease drug Tavneos from the European market after reviewing data they deemed incorrect and misleading. The authorities said the data s…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Bankrupt Sangamo sells Fabry gene therapy to PTC and prion program to Lilly for $161M
    Sangamo Therapeutics, currently in Chapter 11 bankruptcy, has agreed to divest its Fabry disease gene therapy and several other platforms to raise cash for the restructuring. PTC Therapeutics emer…
    BioSpace · 1mo agoDealNeutral↗ source
  • FDA's PDUFA VIII adds 'America First' incentives and speeds up drug reviews
    The Food and Drug Administration announced the next five‑year reauthorization of the Prescription Drug User Fee Act, known as PDUFA VIII. The agency said the new framework will introduce several po…
    Endpoints · 1mo agoRegulatoryPositive↗ source