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  • Boticelli Foods recalls Bettergoods pistachio nut butter over possible Salmonella contamination
    Boticelli Foods of Melville, New York announced a recall of one lot of Bettergoods Pistachio Nut Butter, a 6.7‑oz (190 g) product identified by UPC 194346207961 and lot number LB028ACP04. The reca…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 1mo agoNegative readoutNegative
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Infectious Disease457
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  • Resilience and Eli Lilly commit $750 million to expand Cincinnati GLP-1 injectable production
    Resilience and Eli Lilly announced a joint $750 million investment to expand drug manufacturing capacity in Cincinnati. The expansion will add at least 400 jobs and increase Resilience's workforce…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Sanofi CEO pledges to rebuild trust and expand partnership with Regeneron
    Sanofi's new chief executive, Belén Garijo, told analysts that restoring the relationship with longtime partner Regeneron is a top priority. She said the company wants to be more transparent and to…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Trump administration proposes 340B rebate pilot for 2027, hospitals push back
    The Health Resources and Services Administration announced a new pilot that would shift some 340B drug discounts to rebate payments starting in 2027. The proposal follows a previous attempt earlie…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Lidl US expands recall of Eridanous shortbread cookies over undeclared wheat, soy, milk, egg and coconut allergens
    Lidl US announced it is widening a recall that began on July 24, 2026 to cover all units of its Eridanous Shortbread Cookies that feature foreign-language packaging. The affected items include the…
    fda recalls · 1mo agoRegulatoryNeutral↗ source
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 1mo agoEarningsNegative↗ source
  • Johnson & Johnson secures option to acquire in-vivo CAR-T developer Sail Biomedicines for up to $2.6 billion
    Johnson & Johnson announced a strategic partnership with Sail Biomedicines, a Flagship Pioneering‑backed startup, that includes an upfront cash payment and an equity investment. The initial paymen…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA advisory panel backs Replimune's melanoma therapy RP1, raising approval prospects
    Advisors to the U.S. Food and Drug Administration voted 10-3 in favor of Replimune's experimental melanoma treatment, RP1, despite lingering scientific concerns about the data presented. The panel…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • FTC Sues Hims & Hers for Alleged Illegal Sharing of Patient Data and Deceptive Billing
    The Federal Trade Commission has filed a lawsuit against Hims & Hers, a California‑based telehealth company, accusing it of violating privacy laws. The complaint says the firm used tracking pixels…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Ukrop’s Homestyle Foods voluntarily recalls six baked goods over possible aluminum fragments
    Ukrop’s Homestyle Foods, a Richmond, Virginia based company, announced a voluntary recall of six baked products after a routine inspection found a small piece of aluminum in the baking pan. The re…
    fda recalls · 1mo agoCRLNegative↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 1mo agoEarningsPositive↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • 529 Commerce recalls Rooted in Rare Aquafaba Powder over possible undeclared egg allergen
    529 Commerce, LLC of Parkland, Florida announced a recall of its Rooted in Rare brand Aquafaba Powder. The recall includes 3,860 units packaged in 4‑oz and 12‑oz flexible foil pouches that were so…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Publix recalls all GreenWise Organic frozen blueberries and mixed berries over potential E. coli O145 contamination
    Publix announced a recall of all lots of GreenWise Organic Whole Blueberries and Whole Mixed Berries because the products may be contaminated with Escherichia coli O145:H28. The strain is a Shiga…
    fda recalls · 1mo agoCRLNegative↗ source
  • Claris Bio raises $118M Series B and appoints new CEO to advance eye-drug for limbal stem cell deficiency
    Claris Bio, a New Jersey biotechnology company, announced a $118 million Series B financing round co-led by Samsara BioCapital and Catalio Capital Management, with participation from Sofinnova Inve…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • GSK announces $2.5 billion annual cost-cutting plan to offset upcoming patent cliff
    GSK disclosed in its latest quarterly earnings that it will launch a three-year restructuring aimed at saving about £1.9 billion ($2.5 billion) each year. The plan is intended to cushion the impac…
    BioPharma Dive · 1mo agoLayoffsNeutral↗ source
  • FDA’s AI push faces uncertainty after key leaders depart
    The FDA has been pushing artificial intelligence across the agency, unveiling a large-language-model tool called Elsa to help draft and summarize review reports and announcing plans to use agentic…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Argenx to buy Forte Biosciences for up to $2.2 billion, adding experimental CD122 drug FB102
    Argenx announced it will acquire Forte Biosciences in a transaction valued at up to $2.2 billion. The purchase price is set at $77 per Forte share, roughly a 41% premium to the previous closing pr…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 1mo agoPositive readoutNegative↗ source