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174 stories matching this filter · ← front page

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  • AstraZeneca’s ATTR-CM Silencer Trial Fails to Show Benefit Over Existing Stabilizer Therapy
    AstraZeneca announced that its Phase 3 trial of a silencer drug for transthyretin amyloid cardiomyopathy (ATTR-CM) did not meet its primary endpoints. The study showed no additional clinical benefi…
    STAT · 4h agoNegative readoutNegative↗ source
  • Cytokinetics reports positive pivotal trial results for aficamten in non-obstructive hypertrophic cardiomyopathy
    Biotech Cytokinetics disclosed full data from a pivotal study of its drug aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). The trial met both primary endpoints, showin…
    STAT · 3h agoPositive readoutPositive↗ source
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fda recalls56
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Psychiatry & CNS774
Ophthalmology462
Pain429
Endocrinology & Metabolism406
Infectious Disease386
  • Genentech pays $45M upfront to DualityBio for ADC platform targeting resistant cancers
    Genentech has agreed to pay DualityBio $45 million upfront for rights to its antibody‑drug conjugate (ADC) technology, with the agreement offering more than $1 billion in potential milestone paymen…
    Fierce Biotech · 10h agoDealPositive↗ source
  • Vaccine claims dominate federal autism advisory committee meeting, sidelining research funding plan
    At a recent meeting of the federal autism advisory committee, members spent most of the time discussing vaccines as a possible trigger for autism. The discussion eclipsed the committee’s intended…
    STAT · 5h agoNegative↗ source
  • FDA approves Roivant's new dermatomyositis therapy
    The FDA has granted approval to a therapy developed by Roivant for the treatment of dermatomyositis, a rare autoimmune condition that causes muscle inflammation and skin rash. The decision adds a…
    STAT · 52m agoApprovalPositive↗ source
  • Moderna and Merck report late-stage success for personalized mRNA cancer vaccine
    Moderna and Merck announced that their personalized cancer vaccine achieved its primary goals in a late-stage clinical trial, sparking enthusiasm across the biotech community. The experimental the…
    STAT · 1d agoPositive readoutPositive↗ source
  • CEPI pledges up to $16.5M to advance Egyptian biotech's Ebola vaccine candidate
    CEPI has committed up to $16.5 million to help bring Minapharm’s Bundibugyo Ebola vaccine candidate into clinical testing. The funding will support preclinical work and an early-stage human trial…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA approves Roivant's brepocitinib for rare autoimmune disease dermatomyositis
    On Thursday the U.S. Food and Drug Administration gave its nod to a new therapy from Roivant Sciences and its subsidiary Priovant. The oral medication, brepocitinib, will be sold under the brand na…
    STAT · 18h agoApprovalPositive↗ source
  • Osivax licenses GC Biopharma seasonal flu vaccine to develop combined OVX836-GC FLU shot
    Osivax has secured a non-exclusive license from GC Biopharma for its seasonal influenza vaccine, GC FLU, to pair with Osivax’s mid-phase candidate OVX836. OVX836 targets the conserved nucleoprotei…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Reddit reveals menopause symptoms often misdiagnosed, urging researchers to listen
    A University of Maryland researcher examined discussions on Reddit where women described perimenopause and menopause experiences that were frequently dismissed or misdiagnosed by clinicians. The on…
    STAT · 1d agoNeutral↗ source
  • Chutes & Ladders—Vivace revs up C-suite ahead of pivotal push
    Vivace Therapeutics has named Craig Gibbs, Ph.D., as its new president and CEO.
    Fierce Biotech · 1d ago↗ source
  • Spyre Therapeutics cuts rheumatoid arthritis program after weak Phase 2 TL1A antibody results
    Spyre Therapeutics reported that its Phase 2 study of the anti‑TL1A antibody SPY072 in rheumatoid arthritis did not meet the efficacy expectations set earlier this year. The company said the data f…
    Fierce Biotech · 2d agoNegative readoutNegative↗ source
  • Profit motive highlighted as key to advancing women’s health research and boosting economic productivity
    Experts say that turning to the profit motive could spur investment in under‑funded women’s health areas such as endometriosis, osteoporosis and autoimmune disorders. They note a long history of r…
    STAT · 2d agoNeutral↗ source
  • FDA clears Abbott’s Libre Duo 10-Day sensor to warn of diabetic ketoacidosis
    The U.S. Food and Drug Administration has cleared Abbott’s new wearable device that measures both glucose and ketone levels in people with diabetes. The clearance allows the product to be marketed…
    Fierce Biotech · 2d agoApprovalPositive↗ source
  • Oxford study finds Shingrix linked to lower risk of heart attacks, strokes and heart failure
    Researchers at Oxford University reported that receiving the newer shingles vaccine Shingrix was associated with a reduced risk of cardiovascular disease. The observation follows earlier work by t…
    STAT · 2d agoPositive readoutNeutral↗ source
  • Biotech entrepreneur Someit Sidhu launches JATT III Acquisition SPAC with $60M Nasdaq IPO
    Someit Sidhu, M.D., announced the formation of JATT III Acquisition, a new special purpose acquisition company that raised $60 million in an initial public offering on Nasdaq. The SPAC will seek t…
    Fierce Biotech · 2d agoDealNeutral↗ source
  • Sentivera secures up to $1.5 billion licensing deal for inflammatory disease candidate
    Sentivera, a biotech startup formed by investors behind Metsera, announced a licensing agreement with Shanghai-listed Haisco Pharmaceutical. Under the deal, Sentivera will pay Haisco $40 million u…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Senators say HHS Secretary RFK Jr.’s Gardasil stake explanation contradicts earlier testimony
    A group of U.S. senators have raised concerns about the explanation offered by Robert F. Kennedy Jr., the Health and Human Services secretary, regarding how he disposed of a financial interest tied…
    STAT · 3d agoRegulatoryNegative↗ source
  • Everything Sprouts recalls alfalfa sprouts over possible E. coli and Salmonella contamination
    Everything Sprouts, LLC, a Minneapolis‑based producer, announced a recall of certain lots of its alfalfa sprouts on August 22, 2026. The recall was triggered because the sprouts may be contaminate…
    fda recalls · 6d agoCRLNegative↗ source
  • Merck and Moderna report positive late-stage melanoma vaccine results, adding to 2026 cancer breakthrough year
    Merck and Moderna announced that their personalized mRNA neoantigen vaccine achieved positive outcomes in a late-stage trial for melanoma patients. The data suggest the vaccine can stimulate an imm…
    STAT · 8d agoPositive readoutPositive↗ source
  • Neumora Therapeutics appoints Joshua Pinto as CEO and Doron Sagman as CMO ahead of IND filing
    Neumora Therapeutics announced leadership changes, naming Joshua Pinto, Ph.D., as its new chief executive officer. Pinto, who joined Neumora in 2021 as chief financial officer and most recently se…
    Fierce Biotech · 7d agoNeutral↗ source
  • Pheast Therapeutics sticks with open R&D despite competitor Antengene moving ahead with anti‑CD24 trials
    Pheast Therapeutics, a Redwood City biotech founded in 2021, builds on Irv Weissman’s 2019 Nature paper that highlighted the CD24 protein as a promising "don’t eat me" target for cancer immunothera…
    Fierce Biotech · 8d agoNeutral↗ source
  • Boehringer Ingelheim pauses phase 1 trial of BI 3031185 in Japan to investigate safety event
    Boehringer Ingelheim has placed a phase 1 study of its investigational oral small‑molecule candidate BI 3031185 on voluntary hold after a safety event was reported. The trial, which began in early…
    Fierce Biotech · 7d agoCRLNeutral↗ source
  • B. Braun voluntarily recalls one lot of Excel Lactated Ringers IV solution over particulate contamination
    B. Braun Medical Inc announced a voluntary recall of a specific lot of its Excel Lactated Ringers Injection, a 1000 mL IV solution, after detecting particulate matter in the product. Laboratory an…
    fda recalls · 8d agoCRLNegative↗ source
  • 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 · 9d agoDealPositive↗ source