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425 stories matching this filter · ← front page

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  • FDA releases proposed commitment letter detailing changes to GDUFA IV program
    The U.S. Food and Drug Administration has issued a proposed commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV). The letter follows several months o…
    raps · 8d agoRegulatoryNeutral↗ source
  • Kettle Cuisine recalls Marketside Tomato Bisque Soup Kit sold at Walmart over possible Listeria contamination
    Kettle Cuisine LLC announced a recall of its 14‑oz Marketside Tomato Bisque Soup Kit after discovering a potential contamination with Listeria monocytogenes. Listeria can cause severe illness, esp…
    fda recalls · 8d agoRegulatoryNegative↗ source
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  • Oma's Pride recalls one lot of Woof Complete Canine Chicken Recipe due to possible 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 identified Salmonella contamination.…
    fda recalls · 7d agoRegulatoryNegative↗ source
  • Whole Foods recalls dips, salsas and other prepared foods containing jalapeños over possible Salmonella risk
    Whole Foods Market announced a recall of select produce and prepared-food items that contain jalapeños supplied by Coast Citrus Distributors because of a potential Salmonella contamination. The re…
    fda recalls · 8d agoCRLNegative↗ source
  • Definium's LSD-based therapy shows strong Phase 3 results in generalized anxiety disorder
    Definium Therapeutics reported that its LSD-derived oral tablet, DT120, met its primary endpoint in a Phase 3 trial for generalized anxiety disorder. The study enrolled over 200 participants and co…
    Fierce Biotech · 9d agoPositive readoutPositive↗ source
  • Combination therapy including leronlimab clears HIV in infant macaques, offering new cure hope
    CytoDyn researchers tested leronlimab together with broadly neutralizing antibodies and antiretroviral therapy in a cohort of 55 infant macaques. Only the eight animals that received the full three…
    Fierce Biotech · 9d agoPositive readoutPositive↗ source
  • Epicrispr secures $90M Series C to advance epigenetic therapy for rare muscle disease
    Epicrispr Biotechnologies announced a $90 million Series C financing round, led by Octagon Capital and Janus Henderson Investors, with participation from Sanofi Ventures and other investors. The c…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Hemab Therapeutics IPO raises $301.5M, stock triples and funds runway to 2029
    Hemab Therapeutics completed an upsized $301.5 million IPO in May, boosting total proceeds to $346.7 million. The offering helped the company’s share price climb from $18 at debut to $53.48 by mid‑…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Deerfield-backed Boulevard Bio raises $65 million and unveils three autoimmune drug candidates
    Boulevard Bio, a New York‑based biotech focused on B‑cell biology, announced it has emerged from stealth with $65 million in financing from Deerfield Management. The funding supports the developmen…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Zydus Sentynl signs up to $475M deal to license Mereo's phase-3 ready rare lung disease drug alvelestat in U.S.
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, announced a licensing agreement with Mereo BioPharma for the U.S. rights to alvelestat, a neutrophil elastase inhibitor that has completed…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Abbott partners with Google Health to add AI-driven insights to its Lingo glucose wearable
    Abbott and Google Health announced a partnership that will combine Abbott's Lingo consumer glucose wearable with Google Health's artificial‑intelligence platform. The integration will let Lingo us…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Amgen to open new R&D Science and Innovation Center in Hyderabad's Genome Valley by 2027
    Amgen announced plans to establish a Science and Innovation Center in Hyderabad's Genome Valley, a biotech hub in India. The facility is slated to open in 2027 and will become part of Amgen's globa…
    Fierce Biotech · 9d agoPositive↗ source
  • Aura Biosciences cuts 20% of staff and reshuffles C-suite to focus on ocular oncology
    Aura Biosciences announced it is eliminating about one-fifth of its workforce as part of a broader restructuring under its new chief executive officer, Natalie Holles, who took the helm in April.…
    Fierce Biotech · 9d agoLayoffsNeutral↗ source
  • Lidl US Recalls Vitasia Asian Style Wok Spice Mix Due to Potential Salmonella Contamination
    ARLINGTON, VA – AUGUST 11, 2026 – Lidl US is recalling one lot of Vitasia Asian Style Wok Spice Mix 1.58 oz (45g) (UPC 4335619355491) with Lot # 155846 and BBD JUN 2028 because it has the potential…
    fda recalls · 8d agoRegulatoryNeutral↗ source
  • Henkel recalls Schwarzkopf Professional Osis Grip mousse in U.S. over packaging leak risk
    Henkel Corp announced a voluntary recall of its Schwarzkopf Professional Osis Grip mousse (6.76 fl oz/200 ml) sold in the United States. The recall is due to a potential packaging defect that coul…
    fda recalls · 9d agoCRLNegative↗ source
  • Frankie's Organic recalls vegan cheddar puffs over undeclared milk, warning allergic consumers
    Frankie's Organic Foods Inc. announced a recall of 94 cases of its Plant-Based Vegan Cheddar Puffs after discovering the snack may contain undeclared milk, creating a serious risk for people with m…
    fda recalls · 9d agoCRLNegative↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 9d agoRegulatoryNeutral↗ source
  • PIC/S releases revised guide on qualification and validation studies for pharma manufacturing
    PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities. The new guide is intended for both inspe…
    raps · 9d agoRegulatoryNeutral↗ source
  • WuXi AppTec Co-CEO Stresses Need for True Resilience Beyond Redundancy in Biopharma Innovation
    In a recent Fierce Biotech interview, WuXi AppTec co-CEO Dr. Steve Yang discussed how the biopharma sector can build resilience as scientific challenges grow. Yang said resilience is not just abou…
    Fierce Biotech · 9d agoPositive↗ source
  • Salata Dressings recalls Jalapeno Avocado Dressing over possible Salmonella contamination
    Salata Dressings of Houston, Texas announced a recall of its Jalapeno Avocado Dressing because the product may be contaminated with Salmonella. The recall was issued on August 11, 2026 and the FDA…
    fda recalls · 8d agoCRLNegative↗ source
  • FDA issues early alert after BD needle set defects linked to four deaths
    The FDA’s Center for Devices and Radiological Health released an early alert warning clinicians to stop using Becton Dickinson’s intraosseous vascular access needle sets after reports of serious in…
    Fierce Biotech · 10d agoRegulatoryNegative↗ source
  • Sionna’s cystic fibrosis flop sends stock down 90%, but a ‘significant positive’ for Vertex
    Sionna Therapeutics has axed a cystic fibrosis add-on program after flunking a phase 2 trial, eliminating a would-be challenger to Vertex Pharmaceuticals’ empire. The biotech plans to “take actions…
    Fierce Biotech · 10d agoNegative readoutNegative↗ source
  • AbCellera's Phase 2 hot flash trial beats aggressive upside target, challenging Astellas and Bayer
    AbCellera announced that its Phase 2 study of ABCL635, an antibody that blocks the NK3R receptor, met its primary endpoint in postmenopausal women with hot flashes. The trial enrolled 92 participan…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source
  • Jazz Pharma to acquire Actio Biosciences for $820M, adding KCNT1+ epilepsy drug to its pipeline
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences for an upfront payment of $820 million, expanding its portfolio of epilepsy medicines. The deal brings Actio’s lead candidate, ABS…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Silence Therapeutics’ Phase 2 Trial Shows Strong Efficacy of divesiran in Polycythemia Vera
    Silence Therapeutics reported that its siRNA candidate divesiran met the primary endpoint in a phase 2 study of patients with polycythemia vera. The trial enrolled 48 participants and 88% of those…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source