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60 stories matching this filter · ← front page

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  • Moderna sticks to 10% revenue growth goal despite Phase 3 norovirus vaccine miss
    Moderna said it will continue to aim for up to 10% revenue growth this year, even though its experimental norovirus vaccine did not achieve statistical significance in a Phase 3 interim analysis.…
    BioSpace · 22h agoNegative readoutNeutral↗ 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 · 1d agoRegulatoryNeutral↗ source
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fda recalls23
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Vaccines517
Endocrinology & Metabolism293
Ophthalmology258
Infectious Disease253
Nephrology239
  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 2d agoDealPositive↗ source
  • Biotech earnings season kicks off as Agios reports Phase 2 setback for sickle-cell drug
    The second‑quarter earnings window has begun, and analysts are zeroing in on a handful of biotech companies with high‑profile catalysts. Smaller biotechs are increasingly opting to launch their pr…
    BioSpace · 3d agoNegative readoutNeutral↗ 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 · 3d agoNegative↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 3d agoLayoffsNegative↗ 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 · 4d agoRegulatoryNegative↗ 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 · 3d agoPositive↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 4d agoPositive readoutPositive↗ 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 · 4d 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 · 4d agoNeutral↗ source
  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 7d agoRegulatoryNegative↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 12d ago↗ 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 · 15d 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 · 16d 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 · 17d 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 · 18d 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 · 18d 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 · 21d ago↗ source
  • FDA quietly pushes back deadline on electric shock ban
    Massachusetts' biggest nursing strike ever, tackling the male loneliness epidemic, and other health news for Morning Rounds
    STAT · 22d ago↗ source
  • Transplants extended survival for patients whose stage 4 lung cancer hadn’t spread, study says
    Lung cancer patients hadn't been seen as candidates for organ transplant. Now a study finds patients did well.
    STAT · 23d ago↗ source
  • STAT+: Prime Medicine claims victory in dispute over gene-editing technology with Beam Therapeutics
    Prime Medicine said it had won an arbitration dispute against Beam Therapeutics, a clash that had pitted two well-backed gene-editing companies against each other.
    STAT · 23d ago↗ source
  • FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
    On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ag…
    fda press · 1mo ago↗ source
  • HHS responds coolly to paper on alcohol risk
    Soda and liver cancer, scientists conflicted on a new NIH proposal, and more health news from Morning Rounds
    STAT · 1mo ago↗ source
  • Gilead and Merck’s latest trial success and flop
    AstraZeneca's GLP-1 pill, GSK's $10.6B cancer startup acquisition, and more biotech news from The Readout
    STAT · 1mo ago↗ source