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64 stories matching this filter · ← front page

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  • 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 · 7h agoRegulatoryNeutral↗ source
  • 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 · 1d agoDealPositive↗ source
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fda recalls22
fda press21
fda medwatch17
570
Vaccines507
Endocrinology & Metabolism289
Ophthalmology255
Infectious Disease252
Nephrology234
  • 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 · 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 · 2d 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 · 2d 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 · 2d agoLayoffsNegative↗ source
  • STAT+: GSK lays out plans to cut costs, pursue more late-stage drug trials
    New GSK CEO Luke Miels outlined his strategy to help the company navigate a patent cliff and get on a path toward long-term growth.
    STAT · 3d agoRegulatoryNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and more
    The FDA said a Capricor stem cell treatment for Duchenne muscular dystrophy did not meet a Phase 3 trial's objectives — contrary to company claims
    STAT · 3d agoRegulatoryNeutral↗ source
  • Altimmune rises as GLP-1/glucagon drug curbs heavy drinking in mid-stage study
    Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics, among oth…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Anthony Fauci’s pandemic-era diary entries
    New data on American substance use, concerns of a global HIV resurgence, and more health news from Morning Rounds
    STAT · 3d agoRegulatoryNeutral↗ source
  • STAT+: From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD
    Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.
    STAT · 3d agoRegulatoryNeutral↗ source
  • Altimmune’s next-gen GLP-1 curbs heavy drinking in ‘unequivocal’ ph. 2 alcohol use disorder win
    An experimental drug targeting both GLP-1 and glucagon receptors has curbed heavy drinking in a phase 2 trial, providing hope that the ubiquitous weight loss meds can be effectively harnessed again…
    Fierce Biotech · 3d agoNeutral↗ source
  • GSK unveils 3-year cost-saving plan to fund late-stage R&D, move research HQ to AZ's backyard
    GSK has unveiled an ambitious three-year plan to divert resources to its late-stage R&D programs and shift its research headquarters—but CEO Luke Miels is being tight-lipped about the extent of any…
    Fierce Biotech · 3d 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
  • 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 · 7d agoLayoffsNegative↗ source
  • House passes bill directing FDA to update animal testing rules
    The U.S. House of Representatives passed the FDA Modernization Act 3.0 this week, and lawmakers and animal welfare advocates are celebrating the bill as a step toward a new era in preclinical testi…
    Fierce Biotech · 9d ago↗ 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 · 11d 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 · 14d 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 · 15d 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 · 17d 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 · 17d 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 · 20d 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 · 21d 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