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  • Novo Nordisk seeks injunction to halt Eli Lilly's obesity drug ads
    Novo Nordisk filed a motion in a New Jersey federal court asking for a preliminary injunction that would stop Eli Lilly's advertisements for its obesity treatments. Novo claims the ads are mislead…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 1mo agoCRLNegative↗ source
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  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Scribe Therapeutics raises $129 million in gene-editing IPO, debuting on Nasdaq
    Scribe Therapeutics completed an initial public offering that raised close to $129 million. The company sold 8.58 million shares at $15 each and will trade on Nasdaq under the ticker SCTX. The off…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 1mo agoCRLNegative↗ source
  • Lidl US recalls Eridanous shortbread cookies over undeclared wheat, soy, milk, and egg allergens
    Lidl US announced a recall of its Eridanous Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling, 11.6 oz boxes, after discovering that the packaging was in a foreign language and om…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Eli Lilly to file FDA application for obesity drug retatrutide after Phase 3 trial results
    Eli Lilly announced that two additional Phase 3 trials of its experimental obesity medicine retatrutide met their primary goals, and the company plans to submit an FDA application for the drug next…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • Most FDA-approved drugs meet postmarketing study requirements, and advisory panel backs two peptides for bulk compounding
    A recent analysis published in JAMA Network Open found that nearly nine out of ten drugs approved by the U.S. Food and Drug Administration have completed their postmarketing requirements or commitm…
    raps · 1mo agoRegulatoryNeutral↗ source
  • J&J gets FDA clearance for general surgery robot; study finds 90% of approved drugs meet post-marketing commitments
    J&J received FDA authorization for a general‑surgery robot, a notable regulatory step for the company. The FDA is also being urged to ban direct‑to‑consumer drug advertisements, highlighting ongoi…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EMA seeks input on draft revisions to biosimilar efficacy guidance
    The European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies. The changes are inten…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA advisory panel votes to add two peptides, BPC-157 and KPV, to 503A bulk compounding list
    The FDA’s advisory committee voted 8-6, with one abstention, to recommend that two peptides be placed on the 503A Bulks List for bulk compounding. The recommendation covers BPC-157, proposed for ul…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Midwest Poultry Services recalls over 1.5 million dozen eggs over possible Salmonella Enteritidis contamination
    Midwest Poultry Services, L.P. announced a voluntary recall of 1,589,577 dozen white and brown cage-free shell eggs produced in Texas. The recall was triggered by a potential contamination with Sa…
    fda recalls · 1mo agoCRLNegative↗ source
  • GSK secures FDA approval for lung-cancer drug Jideytro after $10.6 billion Nuvalent acquisition
    GSK received FDA clearance for Jideytro, a therapy for patients with metastatic non‑small cell lung cancer that have ROS1 gene alterations and have already been treated with another targeted drug.…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Arrowhead’s plozasiran cuts triglycerides up to 81% in late-stage trials, shows promise for severe hypertriglyceridemia
    Arrowhead Pharmaceuticals reported positive data from two late-stage studies of its RNA-based drug plozasiran in adults with severe hypertriglyceridemia. The trials used a subcutaneous injection e…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Crystalys Therapeutics raises $130M Series B to advance gout drug dotinurad toward global launch
    Crystalys Therapeutics announced a $130 million Series B financing to move its gout drug dotinurad through late-stage trials and prepare for commercial launch. The round was led by Frazier Life Sc…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Vertex's $10 billion Crinetics buyout draws investor doubts over premium price
    Vertex was the lone bidder in a planned $10 billion acquisition of Crinetics Pharmaceuticals, a California company that focuses on endocrine medicines. Crinetics currently markets a therapy for a…
    BioPharma Dive · 1mo agoDealNegative↗ source
  • Trump threatens 200% tariffs on imported generic drugs to force U.S. production
    President Trump announced on Truth Social that generic drugs imported into the United States could face a 100% tariff starting Aug. 1, 2028, rising to 200% three years later. He framed the measure…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • FDA sends warning letters to Sanofi and Viatris over misleading product claims
    The FDA’s Office of Prescription Drug Promotion issued untitled warning letters to Sanofi and Viatris after reviewing promotional materials that the agency deemed misleading. The letters cite spec…
    raps · 1mo agoRegulatoryNegative↗ source
  • Summit Therapeutics' ivonescimab shows improved survival trend in extended follow-up, easing investor doubts
    A new analysis of Summit Therapeutics and Akeso's dual‑acting cancer immunotherapy ivonescimab indicates that the drug's impact on overall survival has grown with longer observation. The extended d…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 1mo agoNeutral↗ source
  • Novartis beats sales expectations as Q2 revenue rises to $14.4B, eyes upcoming study readouts
    Novartis reported a modest rise in second‑quarter sales, lifting its share price after the company posted a 1% increase in net sales to $14.4 billion, surpassing analyst forecasts for a decline. A…
    BioPharma Dive · 1mo agoEarningsPositive↗ source
  • Novo Nordisk sues Eli Lilly over alleged misleading obesity drug ads
    Novo Nordisk filed a lawsuit in a New Jersey federal court accusing Eli Lilly of deceptive advertising for its GLP-1 obesity medicines. The action follows a cease-and-desist request that asked Lil…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Agios halts development of sickle cell drug tebapivat after mid-stage trial failure
    Agios announced it will stop developing tebapivat for sickle cell disease after a mid-stage trial did not meet expectations. The drug, a next-generation pyruvate kinase activator related to the ap…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelines
    The U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…
    raps · 1mo agoRegulatoryNeutral↗ source