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259 stories matching this filter · ← front page

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  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 21h agoDealPositive↗ source
  • AI fuels a parallel, unregulated medical ecosystem outside traditional care
    Arya Rao, a Harvard‑MIT M.D.-Ph.D. candidate, and Marc Succi, a Harvard radiology professor, argue that financial incentives are pulling major AI firms into health care, creating a shadow system se…
    STAT · 22h agoNegative↗ source
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fda recalls47
fda medwatch36
fda press28
885
Psychiatry & CNS707
Ophthalmology416
Pain371
Endocrinology & Metabolism370
Infectious Disease346
  • Immunologist Liz Marnik, raised unvaccinated, now advocates for science and empathy in vaccine discussions
    Immunologist Liz Marnik grew up in a household that rejected vaccines, and she herself went without any immunizations into adulthood. At age 23 she visited a travel clinic and received all standar…
    STAT · 22h agoPositive↗ source
  • AstraZeneca’s Tagrisso plus Orpathys improves survival in MET-mutated lung cancer
    A new combination therapy using AstraZeneca’s Tagrisso together with Hutchmed’s Orpathys has shown a survival benefit for patients with a specific form of non‑small cell lung cancer. The study focu…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • 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 · 1d agoPositive readoutPositive↗ source
  • Amylyx avexitide cuts serious low blood sugar events by 55% in Phase 3 trial for post bariatric hypoglycemia
    Amylyx Pharmaceuticals reported that its experimental drug avexitide significantly reduced the frequency of serious low blood sugar episodes in a Phase 3 study of patients with post‑bariatric hypog…
    STAT · 1d agoPositive readoutPositive↗ source
  • 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 · 1d agoDealNeutral↗ source
  • Amylyx reports positive pivotal trial results for drug targeting post-bariatric hypoglycemia
    Amylyx announced that its experimental therapy achieved statistically significant improvement in patients who experience severe hypoglycemia after bariatric surgery. The company said the pivotal t…
    STAT · 1d agoPositive readoutPositive↗ 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 · 1d 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 · 1d 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 · 2d 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 · 2d agoNegative readoutNegative↗ 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 · 2d agoPositive readoutPositive↗ source
  • Slate Medicines to merge with Fulcrum Therapeutics after Fulcrum drops sickle-cell drug
    Slate Medicines announced it will combine with Fulcrum Therapeutics in a reverse merger, giving the struggling biotech a new corporate home. Fulcrum had been developing pociredir, a therapy design…
    BioPharma Dive · 2d agoDealNegative↗ source
  • FDA approves Bristol Myers' first oral therapy for advanced multiple myeloma, a new drug class
    The U.S. Food and Drug Administration gave its nod to an oral medication from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug represents the first member of a novel clas…
    STAT · 5d agoApprovalPositive↗ source
  • FDA clears Bristol Myers' Zenbexus, first drug of a new class for advanced multiple myeloma
    The FDA announced approval of an oral therapy from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug, iberdomide, will be marketed as Zenbexus and is intended to be used t…
    STAT · 5d agoApprovalPositive↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 5d agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to Bristol's Zenbexus for multiple myeloma; PBMs adopt TrumpRx pricing; Novartis wins UK Entresto patent
    The U.S. Food and Drug Administration granted accelerated approval to Bristol Myers Squibb's oral therapy Zenbexus for patients with advanced multiple myeloma. The drug represents a new class of tr…
    STAT · 5d agoApprovalPositive↗ source
  • ICER finds AstraZeneca’s blood pressure pill Baxfendy not cost-effective at $10,950 a year
    ICER released a report saying the clinical benefits of AstraZeneca’s new blood pressure medication Baxfendy do not justify its listed price. The agency noted the drug is priced at $10,950 per pati…
    Endpoints · 5d agoRegulatoryNegative↗ source
  • Zealand Pharma sells its rights to Takeda's rusfertide for $100 million ahead of FDA decision
    Zealand Pharma has agreed to sell its economic interest in rusfertide, a peptide drug being developed by Takeda and Protagonist Therapeutics, for $100 million. The transaction comes as the FDA rev…
    Fierce Biotech · 7d agoDealNeutral↗ source
  • Silence Therapeutics' Phase 2 trial shows strong results for divesiran in polycythemia vera, shares jump 30%
    Silence Therapeutics reported that its nucleic‑acid drug divesiran achieved a 69% placebo‑adjusted response rate in a Phase 2 study of polycythemia vera patients. Safety was reported as clean, with…
    BioPharma Dive · 7d agoPositive readoutPositive↗ source
  • Climate change worsens symptoms for people with chronic illnesses, author reports from Chicago smoke events
    The author argues that climate change is already harming health, particularly for those living with chronic conditions, and that the impact is becoming more evident. She describes a recent summer…
    STAT · 7d agoNegative↗ source
  • Postpartum psychiatry remains inadequately understood, case of Lindsay Clancy highlights gaps
    The opinion piece, authored by a neuroscience professor at Tufts, an obstetrics‑psychiatry specialist at NewYork‑Presbyterian and Weill Cornell, and a psychiatry researcher at the University of Vir…
    STAT · 7d agoNegative↗ source
  • Hemab Therapeutics IPO raises $301.5M, stock triples and funds runway to 2029
    Hemab Therapeutics completed an upsized $301.5 million IPO in May, boosting total proceeds to $346.7 million. The offering helped the company’s share price climb from $18 at debut to $53.48 by mid‑…
    Fierce Biotech · 8d agoDealPositive↗ source
  • Swiss startup Vaderis raises $152 million to fund Phase 3 trial of rare bleeding disorder therapy
    Vaderis Therapeutics, a 13‑person Swiss biotech, announced a $152 million Series B financing round aimed at advancing its experimental therapy into a Phase 3 study. The company is testing a treatm…
    Endpoints · 8d agoDealPositive↗ source