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110 stories matching this filter · ← front page

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  • FDA approves Revolution Medicines’ pancreatic cancer drug Rasonque, but patients face delayed access
    The U.S. Food and Drug Administration has granted approval to Rasonque, a new therapy for pancreatic cancer developed by Revolution Medicines. The decision follows clinical data that showed the dru…
    STAT · 3h agoApprovalNeutral↗ source
  • AbbVie’s bispecific T‑cell engager etentamig shows positive phase 3 results in relapsed/refractory multiple myeloma
    AbbVie reported that its bispecific T‑cell engager etentamig met its primary goals in the phase 3 Cervino trial for patients with relapsed or refractory multiple myeloma. The trial demonstrated hi…
    Fierce Biotech · 5d agoPositive readoutPositive↗ source
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fda medwatch65
fda recalls62
fda press38
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Psychiatry & CNS862
Ophthalmology494
Pain473
Endocrinology & Metabolism466
Infectious Disease444
  • Invivyd appoints chairman Marc Elia as CEO ahead of COVID antibody readout
    Invivyd, an infectious-disease biotech, announced that its chairman Marc Elia will also serve as chief executive officer. Elia, who joined the board in 2022 and helped shape the company's scientif…
    Fierce Biotech · 4d agoNeutral↗ source
  • Psilocybin prevents chemotherapy-induced neuropathy in mouse study, effects last up to eight months
    Researchers at MD Anderson reported that a single dose of psilocybin given before chemotherapy blocked the development of pain hypersensitivity in mice. The protective effect persisted for up to ei…
    Fierce Biotech · 5d agoPositive readoutPositive↗ source
  • Opinion: Trump administration’s paperwork surge hampers science and health care
    The opinion piece argues that the Trump administration has expanded paperwork requirements, making it harder for scientists and Medicaid recipients to access services. Citing a federal estimate th…
    STAT · 7d agoNegative↗ source
  • Dietitian Shortage Threatens Trump Administration's Nutrition Initiatives
    The Trump administration's Make America Healthy Again (MAHA) plan has shifted nutrition guidance, promoting more protein, cutting processed foods, and revamping meals in schools, military bases and…
    STAT · 7d agoNegative↗ source
  • New American Headache Society guidelines highlight expanded migraine prevention options
    The American Headache Society and the American Academy of Neurology released updated guidance on migraine prevention, the first revision since 2012. The new recommendations note that the FDA has a…
    STAT · 7d agoRegulatoryPositive↗ source
  • Medicare’s G2211 billing code for relationship-based primary care falls short of expectations
    The Medicare G2211 billing code, added in 2024, lets doctors add $16 to each visit when they provide comprehensive, relationship‑based primary care. It was meant to reward the broader set of servic…
    STAT · 11d agoRegulatoryNegative↗ source
  • Hospitals Mobilize to Challenge $1 Trillion Medicaid Funding Cuts
    Hospital leaders are reacting to a law that will cut nearly $1 trillion in Medicaid funding over the next ten years, prompting a rapid re‑evaluation of their financial models. Lobbyists and execut…
    STAT · 12d agoRegulatoryNegative↗ 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 · 12d 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 · 13d agoApprovalPositive↗ source
  • AI can flag drug theft in hospitals, but alerts need human follow-up, case shows
    In September 2024, a travel nurse at Adventist Health in Bakersfield, California, was observed behaving erratically and was later found to be diverting opioids from a secured cabinet, documenting t…
    STAT · 14d agoNeutral↗ source
  • Cancer screening guidelines overlook residents of long-term care facilities, expert warns
    Kim Johnson, a cancer epidemiologist at Washington University, reflects on the lack of screening guidance for people living in long‑term care after her aunt's death. Her aunt, 78, entered a care f…
    STAT · 14d agoNegative↗ source
  • FDA pushes back decision on Capricor’s Duchenne cell therapy, GSK clears hepatitis B drug in Japan
    The U.S. Food and Drug Administration has extended its review of Capricor Therapeutics' experimental Duchenne muscular dystrophy cell therapy, deramiocel. The agency moved its decision deadline fro…
    BioPharma Dive · 14d agoRegulatoryNeutral↗ source
  • Handshakes in the ER: A simple gesture can ease patient anxiety
    An emergency medicine resident at Northwestern University recounts a recent shift where a patient faced a suspected oncologic emergency. The physician introduced herself with a handshake to the pat…
    STAT · 15d agoPositive↗ source
  • Ambros Therapeutics merges with Werewolf, raises $150M to fund phase 3 trial of rare disease drug
    Ambros Therapeutics announced an all‑stock reverse merger with Werewolf Therapeutics, accompanied by a $150 million private placement. The transaction will see the combined company operate under th…
    Fierce Biotech · 18d agoDealPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 19d agoApprovalPositive↗ source
  • Leo Pharma to acquire experimental rare-skin disease drug dersimelagon in up to $435 million deal
    Leo Pharma announced it will acquire the rights to dersimelagon, an experimental oral therapy currently under FDA review, in a transaction that could total up to $435 million in upfront and near‑te…
    BioPharma Dive · 20d 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 · 20d agoPositive readoutPositive↗ source
  • Leo Pharma signs $435 million deal with Tanabe for rare skin disease drug dersimelagon
    Leo Pharma announced a licensing agreement with Mitsubishi Tanabe Pharma for worldwide rights to dersimelagon, an oral melanocortin-1 receptor agonist targeting rare genetic skin disorders. The dr…
    Fierce Biotech · 22d agoDealPositive↗ source
  • Eli Lilly signs up to $370M ion-channel collaboration with OmniAb
    Eli Lilly has entered a collaboration with antibody platform company OmniAb that could involve up to $370 million in research, development and commercial milestone payments. OmniAb, which was spun…
    Fierce Biotech · 22d agoDealPositive↗ 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 · 21d agoDealNegative↗ source
  • UnitedHealthcare CEO Brian Thompson killed; suspect Luigi Mangione pleads guilty to federal stalking
    Luigi Mangione, 28, pleaded guilty in Manhattan federal court to stalking charges tied to the 2024 killing of UnitedHealthcare chief executive Brian Thompson. He told the court he followed Thompso…
    STAT · 24d agoNegative↗ source
  • Vaccines protect lives: A physician’s reminder of what we lose without them
    Dr. Krutika Kuppalli, an infectious-disease physician and former WHO medical officer, reflects on her frontline work where vaccines were scarce. In Haiti she witnessed a patient die from tetanus,…
    STAT · 26d agoPositive↗ 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 · 27d agoNegative↗ source