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  • 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 · 5d agoCRLNegative↗ source
  • FDA releases weekly update on user fee letters and new HHS regulatory agenda
    The FDA's latest weekly briefing highlighted the release of user fee commitment letters, which outline the agency's financial planning for upcoming fiscal periods. It also introduced a new regulat…
    raps · 6d agoRegulatoryNeutral↗ source
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  • 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 · 5d agoRegulatoryNeutral↗ 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 · 6d 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 · 7d 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 · 7d 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 · 6d 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 · 7d 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 · 7d agoRegulatoryPositive↗ source
  • Karyopharm faces default risk with only a month left to rescue cancer expansion
    Karyopharm Therapeutics, a commercial-stage cancer drugmaker, is confronting severe financial strain as its market capitalization is roughly one‑third of the revenue it expects to generate in 2026.…
    Endpoints · 7d agoNegative↗ source
  • Khartis Therapeutics secures $50 million Series B funding from Forge Life Science Partners, Longwood Fund and Lilly Asia Ventures
    San Diego-based Khartis Therapeutics announced a $50 million Series B financing round. The round was led by Forge Life Science Partners and included participation from Longwood Fund, Lilly Asia Ve…
    Endpoints · 7d agoDealPositive↗ source
  • Zealand Pharma sells rights to rare blood cancer drug rusfertide for up to $100M
    Zealand Pharma entered a royalty purchase and sale agreement with Royalty Pharma, receiving $50 million upfront and the possibility of an additional $50 million after one year. In exchange, Zealan…
    BioSpace · 7d agoDealNeutral↗ source
  • PTC Therapeutics and Eli Lilly to acquire parts of bankrupt Sangamo for up to $264 million
    The gene-editing company Sangamo Therapeutics has filed for bankruptcy, placing its assets up for sale. An auction process has identified two bidders: PTC Therapeutics and Eli Lilly, which togethe…
    Endpoints · 7d agoDealNeutral↗ source
  • July biopharma layoffs down 94% YoY, 466 jobs cut across six companies
    July saw a sharp decline in biopharma workforce reductions, with only 466 employees affected, a 94% drop compared with the same month last year. BioSpace data shows six companies announced or proj…
    BioSpace · 7d agoLayoffsNegative↗ source
  • FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in China
    The U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…
    raps · 7d agoRegulatoryNeutral↗ source
  • Aligned Marketplace secures $20 million to link self-insured employers with primary-care clinics
    Aligned Marketplace is a health‑tech startup that matches self‑insured employers with primary‑care clinics, helping companies provide direct access to medical services for their workers. The compa…
    Endpoints · 7d agoDealPositive↗ source
  • Avalyn Pharma CEO shares personal moment as company prepares for Nasdaq IPO
    Avalyn Pharma and Generate Biomedicines executives talked about the long hours and challenges of preparing their companies for an initial public offering. Avalyn CEO Lyn Baranowski highlighted a m…
    BioSpace · 7d agoPositive↗ source
  • European trade group urges authorities to grant notified bodies access to Eudamed for risk-based oversight
    A trade association representing notified bodies has formally asked EU regulators to allow them to access the Eudamed database. The group says that such access would enable them to apply the risk-…
    raps · 7d agoRegulatoryNeutral↗ source
  • FDA releases draft PDUFA VIII commitment letter outlining goals and enhancements for 2028-2032
    The FDA on Thursday issued a proposed commitment letter for the upcoming PDUFA VIII cycle, which will cover fiscal years 2028 through 2032. The letter sets out the agency's performance targets for…
    raps · 7d agoRegulatoryNeutral↗ source
  • Epilepsy drug from Ovid and Takeda receives fresh start under Perceptive-backed venture
    After about 26 months since two Phase 3 trials failed, the epilepsy treatment candidate originally developed by Ovid Therapeutics and Takeda has been removed from their pipelines. Investment firm…
    Endpoints · 6d agoDealNeutral↗ source
  • Italy’s life‑science sector gains clinical strength and venture capital but still trails Europe’s leaders
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer C. Smith‑Parker talks with Diana Saraceni of Panakès Partners and Fabrizio Calisti of Angelini Ventures about Italy’s life‑science…
    BioSpace · 7d agoNeutral↗ source
  • Grand Central Bakery recalls potato sourdough loaves over possible metal fragments
    Grand Central Bakery of Seattle announced a recall of its potato sourdough bread after discovering that some loaves may contain pieces of metal. The recall includes 20‑oz, 12‑oz and other sized lo…
    fda recalls · 6d agoRegulatoryNegative↗ source
  • Grand Central Bakery recalls Potato Sourdough loaves over possible metal contamination
    Grand Central Bakery of Seattle announced a recall of its Potato Sourdough bread after discovering that some loaves might contain metal fragments. The recall covers loaves sold on August 10, 2026…
    fda recalls · 6d agoNegative↗ source
  • Seven deaths linked to Neurocrine’s Prader-Willi drug Vykat raise safety concerns
    Clinicians have warned that seven patients who received Neurocrine Biosciences' recently approved Prader-Willi syndrome therapy Vykat have died, prompting a new safety alert for the patient communi…
    BioSpace · 8d agoRegulatoryNegative↗ source
  • Definium’s oral LSD candidate DT120 shows strong anxiety reduction in Phase 3 trial
    Definium Therapeutics reported that its single‑dose oral LSD candidate DT120 achieved a statistically significant reduction in anxiety symptoms in a Phase 3 study of generalized anxiety disorder. T…
    BioSpace · 8d agoPositive readoutPositive↗ source