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66 stories matching this filter · ← front page

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  • Safety concerns emerge as radiopharmaceuticals advance in cancer trials
    Radiopharmaceuticals are being hailed for their ability to deliver radiation directly to tumours, potentially sparing surrounding healthy tissue and improving cancer therapy. However, as more cand…
    STAT · 6h agoNegative↗ source
  • AbCellera women’s health data top ‘most aggressive upside scenario,’ putting Astellas and Bayer on notice
    AbCellera has reported phase 2 results “beyond even the most aggressive upside scenario” that its CEO dared to consider, boosting the biotech’s chances of challenging Astellas and Bayer for a women…
    Fierce Biotech · 6h ago↗ source
  • Silence brings the noise to Takeda with phase 2 blood cancer win
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Vaccines594
Endocrinology & Metabolism317
Ophthalmology312
Pain304
Infectious Disease299
A phase 2 trial of Silence Therapeutics’ divesiran has hit its primary endpoint, emboldening the biotech to gear up for late-phase development of a potential challenger to Takeda and Protagonist Th…
Fierce Biotech · 10h ago↗ source
  • FDA approves first mRNA seasonal flu vaccine, mFlusiva, a year after funding cuts
    The U.S. Food and Drug Administration granted approval to mFlusiva, the first mRNA‑based seasonal influenza vaccine, after its advisory committee voted unanimously that the benefits outweigh the ri…
    STAT · 4d agoApprovalPositive↗ source
  • Intellia finds genetic marker linked to liver enzyme spikes in CRISPR ATTR amyloidosis trial
    Intellia Therapeutics announced that analysis of its ongoing CRISPR gene-editing trial for transthyretin (ATTR) amyloidosis has identified a common genetic variant among participants who experience…
    Endpoints · 3d agoNegative readoutNegative↗ source
  • Madrigal spends $255 million on multiple MASH drug deals to complement Rezdiffra
    Madrigal Pharmaceuticals is expanding its MASH pipeline by acquiring several assets that could be used alongside its lead candidate, Rezdiffra. In early 2026 the company paid $50 million to Pfizer…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Opinion: Limb girdle muscular dystrophy patients face a maddening reality
    “Too often, regulatory tools authorized to speed patient access to breakthrough treatments are being used in ways that even prevent approval,” writes Kat Bryant Knudson.
    STAT · 10d agoRegulatoryNeutral↗ source
  • Processa Pharma acquires Vidya Therapeutics, gaining oral BTK inhibitor VT-7208
    Processa Pharmaceuticals announced an all‑stock acquisition of Vidya Therapeutics, a Florida biotech developing an oral BTK inhibitor called VT‑7208. VT‑7208 is being positioned as a next‑generati…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Prolonged hospital stays leave children isolated, urging change
    An author visiting a pediatric ward describes a young, nonverbal child with severe developmental delays who has been waiting months for a life-saving liver transplant. The child lies in a stark, ma…
    STAT · 12d agoNegative↗ source
  • FDA finds Capricor's Duchenne stem cell therapy failed to meet Phase 3 goals, contradicting company claims
    The U.S. Food and Drug Administration announced that the stem cell treatment from Capricor Therapeutics did not achieve the primary objectives in its Phase 3 trial for Duchenne muscular dystrophy.…
    STAT · 13d agoRegulatoryNegative↗ source
  • Altimmune’s pemvidutide cuts heavy drinking days in phase 2 AUD trial
    Altimmune announced that its experimental dual GLP-1/glucagon receptor agonist pemvidutide reduced heavy drinking in a phase‑2 study of alcohol use disorder. In the 24‑week Reclaim trial, particip…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • GSK CEO outlines £1.9bn cost-saving drive and aims to launch 20 Phase 3 trials by year-end
    GSK chief executive Luke Miels presented a three‑year plan to make the company more agile and generate significant cost efficiencies. The strategy targets £1.9 billion in annual savings by 2029, wi…
    STAT · 13d agoPositive↗ source
  • GSK launches three-year £1.9bn savings plan to boost late-stage R&D and relocate research HQ
    GSK announced a three-year cost-saving programme designed to free cash for its late-stage research and development pipeline while moving its research headquarters. The plan targets annual savings…
    Fierce Biotech · 13d agoNeutral↗ source
  • Biotech firms rush to develop gene-editing cure for rare alpha-1 antitrypsin deficiency
    A wave of biotech companies is intensifying efforts to cure alpha-1 antitrypsin deficiency (AATD), a rare liver and lung disorder, using gene-editing approaches. Companies such as Beam, Wave Life…
    STAT · 13d agoNeutral↗ source
  • CDC survey shows racial gaps in diagnosis of endometriosis, PMOS and uterine fibroids among US women
    A recent CDC National Center for Health Statistics report based on a 2022-2023 survey of about 5,000 women ages 20 to 49 provides new insight into how often certain gynecologic conditions are diagn…
    STAT · 13d agoNeutral↗ source
  • Amgen cuts about 40 jobs, about 0.1% of workforce, amid ongoing challenges
    Amgen announced the layoff of roughly 40 employees, representing about 0.1% of its global staff, as part of organizational changes aimed at aligning operations with strategic objectives. The compan…
    Fierce Biotech · 16d agoLayoffsNegative↗ source
  • Ipsen's Bylvay fails Phase 3 trial in children with biliary atresia
    Ipsen announced that its experimental therapy Bylvay did not meet its primary endpoint in a Phase 3 trial targeting biliary atresia in infants. Biliary atresia is a rare pediatric liver disorder i…
    Endpoints · 16d agoNegative readoutNegative↗ source
  • House passes FDA Modernization Act 3.0 to push update of animal testing regulations
    The U.S. House approved the FDA Modernization Act 3.0, a bill aimed at modernizing preclinical testing rules. The legislation requires the FDA to revise regulations that still reference animal tes…
    Fierce Biotech · 19d agoRegulatoryPositive↗ source
  • Pete Hegseth’s announcement of annual testosterone screenings for service members divides medical experts
    Medical experts are divided on Defense Secretary Pete Hegseth’s announcement that U.S. service members will undergo annual testosterone screenings.
    STAT · 24d ago↗ source
  • Cassidy grills Trump nominee on past vaccine comments in heated exchange
    Sean Kaufman, Trump's pick for a key pandemic preparedness role, has questioned vaccines and criticized the CDC.
    STAT · 25d ago↗ source
  • STAT+: Akero team, backed by Fairmount, launches new immunology company
    FDA approves injectable Leqembi, another post-Makary reversal, and other biotech news from The Readout
    STAT · 27d ago↗ source
  • FDA authorized Zyn nicotine pouches without knowing what they were made of, says former agency scientist
    A former FDA toxicologist has accused the agency of authorizing Zyn nicotine pouches without fully reviewing their safety
    STAT · 27d ago↗ source
  • 12 ideas for tackling the U.S. alcohol epidemic
    The U.S. can save lives from excess alcohol use without taking drastic measures. Here are 12 steps that can help.
    STAT · 27d ago↗ source
  • Nominee for key federal health role has a history of questioning vaccines
    Sean Kaufman's views on vaccines may put him at odds with Sen. Bill Cassidy during next week's confirmation hearing.
    STAT · 1mo ago↗ source
  • FDA rejects Hengrui-Elevar liver cancer drug combo for third time
    For the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat th…
    Endpoints · 1mo ago↗ source