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189 stories matching this filter · ← front page

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  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 16h agoRegulatoryNeutral↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 19h agoNegative readoutNegative↗ source
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Vaccines611
Endocrinology & Metabolism319
Ophthalmology313
Pain306
Infectious Disease300
  • FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy
    The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
    STAT · 15h agoRegulatoryNegative↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 19h agoNegative readoutNegative↗ source
  • Replimune secures FDA accelerated approval for melanoma therapy Tudriqev
    Replimune announced that the FDA has granted accelerated approval to its melanoma therapy RP1, marketed as Tudriqev, after two earlier rejections and a third expedited review. The decision reflects…
    STAT · 3d agoApprovalPositive↗ source
  • Boston-born biotech founder Felix Wong launches AI-driven startup in California
    Felix Wong grew up near Boston, earned two degrees at Harvard and completed a post-doc at MIT before launching his biotech company in California. His startup applies artificial intelligence to ide…
    STAT · 3d agoNeutral↗ source
  • FDA grants accelerated approval to Replimune’s melanoma therapy Tudriqev after two prior rejections
    The Food and Drug Administration has granted accelerated approval to Replimune’s RP1 treatment, which will be marketed under the name Tudriqev, for patients with advanced melanoma. An advisory com…
    STAT · 4d agoApprovalPositive↗ source
  • FDA approves first mRNA seasonal flu vaccine, mFlusiva, a year after funding cuts
    The U.S. Food and Drug Administration granted approval to mFlusiva, the first mRNA‑based seasonal influenza vaccine, after its advisory committee voted unanimously that the benefits outweigh the ri…
    STAT · 4d agoApprovalPositive↗ source
  • Study uncovers tau’s role in reversing mitochondrial electron flow, offering new Alzheimer’s drug target
    A Stanford-led research team has identified a previously unknown way that the protein tau disrupts cellular function, adding to its status as a leading target in Alzheimer’s drug development. The…
    STAT · 4d agoPositive readoutPositive↗ source
  • FDA approves Takeda’s narcolepsy drug and the first mRNA flu vaccine
    The U.S. Food and Drug Administration has granted approval to a new narcolepsy treatment developed by Takeda, marking a significant addition to the therapeutic options for the sleep disorder. In a…
    STAT · 4d agoApprovalPositive↗ source
  • Tenax Therapeutics to Release Phase 3 Heart Failure Trial Results Soon
    Tenax Therapeutics announced that it will soon disclose data from its Phase 3 trial of a heart-failure treatment. The study is being watched as one of the largest binary events left for biotech st…
    STAT · 4d agoNeutral↗ source
  • AI’s role in medicine isn’t monolithic, says industry leader, urging nuanced adoption
    Priya Abani, CEO of health‑tech firm AliveCor, argues that asking whether AI is good for medicine is a question with an obvious answer: it is. She says the debate has become redundant and that the…
    STAT · 4d agoPositive↗ source
  • Braveheart Bio raises $383 million in Nasdaq IPO to advance Hengrui cardiovascular drug to Phase 3
    Braveheart Bio, a U.S. biotech spun out of China’s Hengrui Pharmaceuticals, completed an initial public offering on the Nasdaq. The offering generated about $383 million in gross proceeds, providi…
    Endpoints · 5d agoDealPositive↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda recalls · 5d agoCRLNegative↗ source
  • Physician reflects on Quebec's assisted-suicide landscape through Josée Lamère’s story
    Sai Rajagopal, a Canadian physician and researcher, writes an opinion piece that follows the life of Josée Lamère, who became one of the 7.9 percent of Quebecers who have chosen assisted suicide. H…
    STAT · 6d agoNeutral↗ source
  • In-patient cardiac pre-hab program launched to keep heart-transplant candidates fit while awaiting surgery
    Patients waiting in the hospital for a heart transplant often lose strength and can become ineligible for the procedure as their fitness declines. To address this, Dr. Radha Gopalan at Banner‑Univ…
    STAT · 7d agoPositive↗ source
  • Medical schools debate AI scribes as teaching tools versus learning crutches
    Hospitals have rapidly adopted AI-powered note-taking tools, saying they reduce physician burnout and boost revenue. Medical schools, however, are cautious. While they want graduates to be comfort…
    STAT · 7d agoNeutral↗ source
  • New York Senate advances assisted-dying bill as Nebraska Medicaid work rules spark coverage losses
    The New York Senate moved forward with legislation that would allow assisted dying, marking a significant step toward legalizing the practice in the state. In Nebraska, the recent implementation o…
    STAT · 7d agoNeutral↗ source
  • Neurologist Who Diagnoses ALS Patients Receives Own Diagnosis, Reflects on Impact of Disability
    Dr. Christopher Campos, a neurologist and assistant professor at UC Davis Health, disclosed that he was diagnosed with amyotrophic lateral sclerosis (ALS) in 2025 after a decade of delivering the s…
    STAT · 7d agoNegative↗ source
  • Novo Nordisk's late-stage anti-inflammatory heart drug fails Phase 3 trial
    Novo Nordisk announced that its experimental anti-inflammatory compound designed to target cardiovascular inflammation did not meet its primary endpoint in a Phase 3 trial. The study was intended…
    Endpoints · 10d agoNegative readoutNegative↗ source
  • Novo Nordisk's anti-inflammatory drug ziltivekimab fails to cut major heart events in Phase 3 trial
    Novo Nordisk reported that its investigational anti‑inflammatory antibody, ziltivekimab, did not reduce the incidence of major cardiovascular events in a pivotal Phase 3 study. The trial enrolled…
    STAT · 10d agoNegative readoutNegative↗ source
  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 11d agoRegulatoryNegative↗ source
  • FDA advisory panel advises against approving Capricor’s Duchenne cell therapy, deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee convened to evaluate deramiocel, a cell‑based treatment for Duchenne muscular dystrophy developed by Capricor Therapeutics. Capricor…
    STAT · 12d agoRegulatoryNegative↗ source
  • New name for PCOS aims to boost awareness and diagnosis for Black and Latina women
    Bontle Moka-Moliki, a 32-year-old from Atlanta, was diagnosed with endometriosis in 2019, fibroids a year later, and in 2024 received a diagnosis of a condition now called polyendocrine metabolic o…
    STAT · 13d agoPositive↗ source