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105 stories matching this filter · ← front page

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  • Vertex, ahead of FDA decision, calms fears surrounding kidney drug
    On a conference call, executives expressed conviction in the coming launch of an IgA nephropathy medicine viewed by Wall Street investors as important to Vertex’s future.
    BioPharma Dive · 5d agoEarningsNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 9d agoApprovalPositive↗ source
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Psychiatry & CNS1162
Ophthalmology984
Endocrinology & Metabolism768
Pain766
Nephrology735
  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 9d agoDealPositive↗ source
  • Vitality Works recalls 365 Whole Foods Ashwagandha capsules over possible Salmonella contamination
    Vitality Works Inc., based in Albuquerque, NM, announced a recall of one lot of its 365 Whole Foods Market Standardized + Full Spectrum Blend Ashwagandha capsules, 120-count, due to potential Salmo…
    fda recalls · 9d agoRegulatoryNegative↗ source
  • Lycia Therapeutics raises $318 million in IPO to fund protein degrader programs
    Lycia Therapeutics, a biotech focused on protein-degrading medicines, priced its initial public offering at about $318 million. The proceeds will be used to advance three LYTAC drug candidates, in…
    BioPharma Dive · 17d agoDealPositive↗ source
  • Moderna and Merck vaccine plus Keytruda cuts melanoma relapse risk by 42% in late-stage trial
    A late-stage adjuvant study of Moderna’s experimental melanoma vaccine, intismeran autogene, combined with Merck’s Keytruda showed a 42% reduction in the risk of relapse or death compared with Keyt…
    BioPharma Dive · 17d agoPositive readoutNeutral↗ source
  • FDA launches Neuroscience Advancement and Innovation Nexus to boost brain disorder drug development
    The U.S. Food and Drug Administration announced a new program called the Neuroscience Advancement and Innovation Nexus (NAIN) aimed at accelerating the development of medical products for brain and…
    fda press · 17d agoRegulatoryPositive↗ source
  • ICER reports two-thirds of new drugs launched 2022-2025 priced well above cost-effectiveness thresholds
    ICER’s latest analysis of launch prices for new prescription medicines shows a sharp rise in net costs between 2022 and 2025. After adjusting for inflation, the median price climbed from $190,000 i…
    BioPharma Dive · 19d agoNegative↗ source
  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 19d agoApprovalPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic porphyria
    Disc Medicine announced that its experimental therapy bitopertin achieved its primary and secondary goals in a Phase 3 trial for erythropoietic porphyria, a rare condition that makes patients extre…
    BioPharma Dive · 20d agoPositive readoutPositive↗ source
  • Lidl US recalls Gelatelli Coffee & Vanilla Gelato over possible Listeria contamination
    Lidl US announced a recall of one lot of its Gelatelli Coffee & Vanilla Gelato with coffee sauce and cookie pieces, citing potential contamination with Listeria monocytogenes. The affected product…
    fda recalls · 24d agoCRLNegative↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 25d agoApprovalPositive↗ source
  • Krasnyi Oktyabr Recalls Starfish Seafood Trio Over Listeria Risk
    Krasnyi Oktyabr Inc. of Brooklyn, New York announced a voluntary recall of its Starfish Seafood Trio, which includes cold smoked salmon, halibut and trout packaged in 8‑oz vacuum‑sealed packs. The…
    fda recalls · 1mo agoCRLNegative↗ source
  • Krasnyi Oktyabr Inc. Recalls Starfish Seafood Premium Cold Smoked Norwegian Salmon Sliced (227g/8oz) Because of Possible Health Risk
    Krasnyi Oktyabr Inc. of Brooklyn, New York, is voluntarily recalling STARFISH SEAFOOD PREMIUM COLD SMOKED NORWEGIAN SALMON SLICED (227g/8oz) packages, because the product has the potential to be co…
    fda recalls · 1mo ago↗ source
  • Argenx shares tumble 15% after Phase 3 Sjögren’s study of Vyvgart halted for futility
    Argenx reported that an independent monitoring board recommended stopping its Phase 3 trial of Vyvgart in Sjögren’s disease due to futility, based on an interim analysis. The decision came earlier…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Viatris to acquire Pacira BioSciences for $1.65 billion, adding two non-opioid pain drugs
    Viatris announced Thursday it will purchase Pacira BioSciences for $1.65 billion in cash, paying $36.50 per share, a 45% premium to the prior close. The acquisition gives Viatris control of Pacira…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Gardeners Basics Recalls Waltham 29 Broccoli Sprouting Seeds Due to Possible Salmonella Contamination
    October 8, 2026, Gardeners Basics of Spanish Fork, Utah, is recalling one-pound bags of broccoli sprouting seeds because they may be contaminated with Salmonella, an organism which can cause seriou…
    fda recalls · 1mo ago↗ source
  • Eden Brothers recalls Calabrese broccoli seeds over possible Salmonella contamination
    Eden Brothers LLC announced a recall of its Calabrese broccoli seeds after being informed by its supplier that the product may be contaminated with Salmonella. The recall includes 1‑ounce and 1‑po…
    fda recalls · 1mo agoCRLNegative↗ source
  • EAK Distribution recalls Home Grown broccoli seed packets over possible Salmonella contamination
    EAK Distribution LLC announced on October 2, 2026 that it is recalling its 8‑oz Home Grown Green Sprouting Calabrese Broccoli Seeds due to a potential Salmonella contamination. The company warned…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Gias Foods recalls Bettergoods Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of all lot codes of its Bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated possible contamination with Listeria monocyt…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Amgen's Dazodalibep Shows Positive Results in First Phase 3 Trial for Sjögren’s Syndrome
    Amgen announced that its experimental drug dazodalibep, acquired through the Horizon Therapeutics acquisition, met the primary endpoint in the first of two Phase 3 trials for Sjögren’s syndrome, a…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Global Mix Inc. recalls Niwali Tejocote supplements after FDA finds toxic yellow oleander content
    Global Mix Inc., based in Middle Village, New York, announced a recall of its Niwali Tejocote Capsules and Pieces, both marketed as herbal dietary supplements. The FDA’s analysis indicated the pro…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Healthcare systems lag behind rapid expansion of GLP-1 therapies, raising care and trust challenges
    GLP-1 drugs have demonstrated that pharmacological treatment can effectively reduce obesity, and regulators have now approved them for additional uses such as cardiovascular risk reduction, metabol…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Compass eyes J&J’s Spravato playbook for upcoming psychedelic drug COMP360 launch
    Compass executives told BioPharma Dive that, if the FDA approves their treatment, they plan to follow the commercial strategy Johnson & Johnson used for its ketamine spray Spravato. When Spravato…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Gias Foods recalls bettergoods Italian Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of two lots of its bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated a potential contamination with Listeria monocytog…
    fda recalls · 1mo agoRegulatoryNeutral↗ source