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943 stories matching this filter · ← front page

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  • Early regulatory operations planning key to submission-ready dossiers
    Regulatory operations are often treated as a final step after all scientific data are compiled, but the article argues they should be integrated from the start of a development program. A dossier…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • Sobi pens $580M deal for Innate’s skin cancer drug ahead of phase 3 push
    Sobi has bought into Innate Pharma’s vision for lacutamab, handing the French biotech $75 million upfront for the rights to market the anti-KIR3DL2 antibody for an aggressive skin cancer.
    Fierce Biotech · 1mo agoDealNeutral↗ source
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Infectious Disease457
  • Novo Nordisk partners with Amazon Web Services to boost AI-driven drug discovery, opens London hub
    Novo Nordisk announced a partnership with Amazon Web Services aimed at using artificial intelligence to speed up the discovery of new medicines. The collaboration will see AWS become Novo Nordisk's…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Taylor Fresh Foods recalls jalapeño-containing products over possible Salmonella contamination
    Taylor Fresh Foods announced a recall of finished products that contain jalapeño peppers after being notified of a voluntary recall by Coast Citrus Distributors due to potential Salmonella contamin…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • NatureBest Precut & Produce recalls jalapeño-containing products over possible Salmonella contamination
    NatureBest Precut & Produce LLC announced a voluntary recall of food items containing jalapeño peppers supplied by Coast Citrus Distributors because of potential Salmonella contamination. The reca…
    fda recalls · 1mo agoCRLNegative↗ source
  • Novo Nordisk CFO sees oral Wegovy rollout boosting outlook and remains upbeat on CagriSema
    Novo Nordisk's chief financial officer, Karsten Munk Knudsen, discussed the company's second‑quarter earnings and the progress of the oral Wegovy pill during a recent interview. He highlighted that…
    Fierce Biotech · 1mo agoEarningsPositive↗ source
  • Revolution Medicines sees strong demand for pancreatic cancer drug daraxonrasib under compassionate use
    Revolution Medicines reports that more than 2,000 patients have received its pancreatic cancer candidate daraxonrasib through a compassionate use program. The company says the drug has been distri…
    BioPharma Dive · 1mo agoPositive↗ source
  • Bristol Myers Squibb expands Nvidia partnership to build most powerful AI supercomputer for drug discovery
    Bristol Myers Squibb announced an expanded partnership with Nvidia that will give it the most powerful and energy-efficient Nvidia infrastructure owned by a life-science company. Nvidia says the p…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • BlossomHill and Latigo Biotherapeutics raise over 30% beyond IPO targets
    Two emerging biotech companies surpassed their initial public offering expectations on Friday, with both BlossomHill Therapeutics and Latigo Biotherapeutics raising at least 30% more capital than p…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • BioMarin halts development of BMN 401 after phase 3 miss
    BioMarin Pharmaceutical announced it is ending all work on its experimental enzyme replacement therapy BMN 401 following a late‑stage trial that did not meet one of two primary goals in patients wi…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Latigo Biotherapeutics raises $345.6M in IPO to fund non-opioid pain drug pipeline
    Latigo Biotherapeutics, a Los Angeles-based biotech focused on non-opioid ion-channel-blocking pain therapies, completed an initial public offering on Thursday. The company sold 19.2 million share…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Ensoma cuts staff again to focus on lead gene therapy for rare immune disease
    Boston‑based biotech Ensoma announced another round of layoffs as it narrows its efforts to its sole clinical candidate, EN‑374, aimed at treating X‑linked chronic granulomatous disease (X‑CGD). E…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source
  • Roche launches cyclospora PCR tests as lettuce-linked outbreak spreads across 15 US states
    Roche Diagnostics announced the rollout of two new real-time PCR assays that detect the parasite Cyclospora cayetanensis. The launch comes as the CDC and FDA report that the cyclospora outbreak li…
    Fierce Biotech · 1mo agoPositive↗ source
  • Lexunder’s Food to Live green powder recalled over possible Salmonella contamination
    Lexunder Inc., operating as Food to Live, announced a recall of its green powder products due to potential Salmonella contamination. The recall covers products sold nationwide in resealable pouche…
    fda recalls · 1mo agoCRLNegative↗ source
  • FDA grants emergency use authorization for CLiK Extra wound spray to prevent New World screwworm in livestock and wildlife
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for CLiK Extra, a dicyclanil topical suspension designed to be applied around wounds. The authorization allows the pr…
    fda press · 1mo agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1
    The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • FDA approves Moderna's first mRNA flu vaccine for adults 50 and older
    The Food and Drug Administration has granted approval to Moderna's mRNA flu vaccine, called mFlusiva and previously known as mRNA-1010, making it the first preventive flu shot built on messenger RN…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Replimune's oncolytic virus therapy Tudriqev receives FDA accelerated approval for advanced melanoma
    The U.S. Food and Drug Administration has granted approval to Replimune's melanoma treatment, ending a series of earlier rejections after an advisory panel advocated for the drug. The therapy, pre…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Tarsus to acquire eye-drug startup Alkeus in up to $800 million deal
    Tarsus Pharmaceuticals announced Thursday that it will buy Alkeus Pharmaceuticals for up to $800 million, consisting of $270 million in cash and $180 million in stock. The agreement also provides…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • BioNTech appoints former Sobi chief Guido Oelkers as new CEO
    BioNTech has filled its long-vacant chief executive position after a six-month search. The board selected Guido Oelkers, Ph.D., who most recently led Swedish pharmaceutical company Sobi. At Sobi,…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Erica Schwartz confirmed as CDC director after year-long leadership void
    Senate confirmed Erica Schwartz, a public-health veteran and vaccine supporter, as the new head of the CDC. She takes over an agency that has operated without a permanent director for almost a yea…
    BioPharma Dive · 1mo agoNeutral↗ source
  • LifeMine secures $263M to advance fungal-derived organ transplant drug
    LifeMine Therapeutics announced it has closed two venture financings that together raised $263 million. The capital will be used to push its experimental therapy, LIFE-001, further along the develo…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Tarsus to acquire Alkeus for $450 million, adding phase-3 retinal drug and oral Stargardt candidate
    Tarsus Pharmaceuticals announced it will buy Alkeus Pharmaceuticals in a transaction valued at $450 million. The deal consists of $270 million in cash and $180 million of Tarsus common stock, givi…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • BioVie’s Parkinson drug data prompts 50% stock drop as company shifts to composite endpoint
    BioVie announced phase 2 results for its experimental Parkinson’s therapy bezisterim, saying the data suggest a meaningful advance in treating the disease. Investors reacted sharply, wiping out ro…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source