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1,657 stories matching this filter · ← front page

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  • Amylyx reports avexitide cuts severe hypoglycemia by 55% in bariatric surgery patients
    Amylyx Pharmaceuticals announced that its GLP-1 blocker avexitide achieved the primary endpoint in a late‑stage trial, reducing serious to severe hypoglycemic events by 55% compared with placebo in…
    BioPharma Dive · 25d agoPositive readoutPositive↗ source
  • BioMarin to acquire Alesta Therapeutics for $275 million to expand bone disease pipeline
    BioMarin Pharmaceutical announced it will purchase Alesta Therapeutics for an upfront payment of $275 million. Alesta is developing an oral small-molecule drug, ALE1, aimed at treating hypophospha…
    Fierce Biotech · 25d agoDealPositive↗ source
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  • Craif raises $33M to expand its urine-based pancreatic cancer test
    AI biopharma Craif announced a $33 million Series D financing, bringing its total capital raised to $88 million. The funding will be used to scale research on its urine-based microRNA test, miSign…
    Fierce Biotech · 25d agoDealNeutral↗ source
  • J&J MedTech secures FDA 510(k) clearance for Monarch Quest 3 bronchoscopy software update
    Johnson & Johnson MedTech announced that its Monarch bronchoscopy robot has received FDA 510(k) clearance for the latest software version, Monarch Quest 3. This marks the fourth major software laun…
    Fierce Biotech · 25d agoRegulatoryPositive↗ source
  • CSL Vifor warns Tavneos exit from Europe will cut revenue by about 25%
    CSL Vifor’s parent company CSL Limited said the withdrawal of the drug Tavneos from the European market creates a significant headwind for sales. The company expects its revenue to fall by roughly…
    Endpoints · 24d agoRegulatoryNegative↗ source
  • BioMarin to buy Alesta Therapeutics for $275M, adding rare bone disease drug to pipeline
    BioMarin announced Tuesday that it will acquire privately held Alesta Therapeutics, paying $275 million upfront with potential additional payments tied to milestones. The deal, expected to close b…
    BioPharma Dive · 24d agoDealPositive↗ source
  • Kolon TissueGene cuts 37 jobs after phase 3 osteoarthritis trial fails
    Kolon TissueGene announced it will lay off 37 employees at its Maryland headquarters, with the reductions set to take effect at the end of August. The cuts follow a phase 3 trial of the company’s…
    Fierce Biotech · 24d agoLayoffsNegative↗ source
  • Third patient dies in Chinese trial of RiboX Therapeutics' experimental genetic therapy
    A patient with an autoimmune disease died after receiving an experimental genetic medicine from RiboX Therapeutics, a Shanghai‑based biotech startup. The death marks the third fatality reported in…
    Endpoints · 24d agoNegative↗ source
  • Harvard researchers keep brain organoids alive for five years, tracking development
    A study published in Nature describes how researchers at Harvard University grew a human brain organoid from a blood sample and kept it alive in the lab for five years. During the five-year period…
    Fierce Biotech · 24d agoPositive↗ source
  • Amylyx reports Phase 3 success for avexitide in post-bariatric hypoglycemia
    Amylyx announced a late-stage success for avexitide, a GLP-1 receptor antagonist, in a Phase 3 trial targeting post-bariatric hypoglycemia. The trial results showed the drug achieved its primary e…
    Endpoints · 25d agoPositive readoutPositive↗ source
  • Leo Pharma to license Tanabe’s oral drug for rare light-sensitive skin disease, paying up to $435 million
    Leo Pharma announced a licensing agreement with Japan's Tanabe Pharma for an oral treatment targeting two genetic skin disorders that cause pain when exposed to sunlight. Under the deal, Leo Pharm…
    Endpoints · 25d agoDealNeutral↗ source
  • BioMarin signs new deal for early-stage bone disease asset
    BioMarin recently halted development of a rare disease drug that it had acquired in a $270 million transaction. Within a week, the company announced another deal to acquire an early‑stage asset aim…
    Endpoints · 24d agoDealNeutral↗ source
  • Biden-era law, not Trump, drives 2026 drop in brand-drug list prices
    List prices for brand-name drugs fell sharply in 2026, marking a notable decline from previous years. Industry experts attribute the reduction primarily to a law enacted during the Biden administr…
    Endpoints · 24d agoRegulatoryNeutral↗ source
  • Epic faces mounting pressure ahead of annual customer meeting
    Reporter Ngai Yeung spent Monday night in downtown Madison, Wisconsin, sampling cheese curds and chatting with attendees before the keynote of Epic's annual customer meeting. The atmosphere at the…
    Endpoints · 24d agoNegative↗ source
  • Dreyer’s Grand Ice Cream voluntarily recalls select Outshine Fruit Bars over possible glass contamination
    Dreyer’s Grand Ice Cream announced a voluntary recall of certain Outshine Fruit Bars after detecting possible foreign material contamination. The recall includes Strawberry, Watermelon, Grape, Tan…
    fda recalls · 24d agoCRLNegative↗ source
  • L-Nutra recalls Prolon Apulian Almond & Cocoa Spread due to undeclared cashews, pistachios, hazelnuts
    L-Nutra of Culver City, California announced a recall of its Prolon brand Apulian Almond & Cocoa Spread after testing found undeclared tree nut allergens. The affected product is sold in 8.47‑oz (…
    fda recalls · 25d agoRegulatoryNegative↗ source
  • FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax
    Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.
    BioPharma Dive · 25d agoApprovalPositive↗ source
  • Argenx reports positive Phase 3 results for Vyvgart Hytrulo in myositis
    Argenx announced that its subcutaneous formulation of Vyvgart, named Vyvgart Hytrulo, met the primary endpoint in a late‑stage Phase 3 trial in patients with myositis. The trial combined participa…
    BioPharma Dive · 25d agoPositive readoutPositive↗ source
  • EyePoint shares tumble as Durayvu misses primary goal in wet AMD trial
    EyePoint, a Boston biotech, saw its market value drop by nearly $1 billion after its lead candidate Durayvu failed to demonstrate non-inferiority to aflibercept in a pivotal phase 3 trial for wet a…
    BioPharma Dive · 25d agoNegative readoutNegative↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of bispecific antibody volrustomig after interim data miss survival goal
    AstraZeneca announced termination of the Phase 3 study of its experimental bispecific antibody volrustomig in non‑small cell lung cancer. An interim data review by trial monitors indicated the dru…
    BioPharma Dive · 25d agoNegative readoutNegative↗ source
  • AstraZeneca reports positive late-stage results for Tagrisso-Orpathys combo and Enhertu in lung cancer
    AstraZeneca said on Monday that two separate late-stage studies in lung cancer have produced positive outcomes. One study evaluated a combination of the tyrosine-kinase inhibitor Tagrisso with the…
    Endpoints · 25d agoPositive readoutPositive↗ source
  • Eli Lilly signs up to $370 million ion-channel collaboration with OmniAb
    Eli Lilly announced a collaboration and licensing agreement with California-based drug discovery company OmniAb that will focus on ion-channel targets. The deal could see Lilly paying up to $370 m…
    Endpoints · 25d agoDealNeutral↗ source
  • Slate Medicines secures $245M financing and Nasdaq listing via reverse merger with Fulcrum Therapeutics
    Slate Medicines, a North Carolina biotech, is moving toward a Nasdaq listing through a reverse merger with Fulcrum Therapeutics, six months after emerging from stealth. The transaction includes a…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Chinese biotech CEOs say US tensions won’t curb booming licensing deals
    Chinese biotech CEOs say they are not worried about rising US political tension and regulatory scrutiny. US lawmakers have increased scrutiny, referencing the America First Investment Policy and t…
    Fierce Biotech · 26d agoNeutral↗ source
  • Amylyx's avexitide halves hypoglycemia episodes in phase 3 trial for post‑bariatric patients
    Amylyx Pharmaceuticals reported that its GLP‑1 receptor antagonist avexitide significantly reduced dangerous blood‑sugar drops in a phase 3 study. The double‑blind Lucidity trial enrolled 78 indiv…
    Fierce Biotech · 25d agoPositive readoutPositive↗ source