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  • Geriatrician urges careful use of AI predictions for older patients
    Artificial intelligence tools are being added to electronic health records to flag patients at risk for conditions such as sepsis, falls or even death. The ease of integration has led many clinicia…
    STAT · 1mo agoNeutral↗ source
  • Rise in Young Men Seeking Cosmetic Surgery Driven by Social Media Influence, Surgeon Observes
    A board‑certified plastic surgeon in Boston reports that more young men are now filling her waiting room than ever before, making men the fastest‑growing group in aesthetic procedures. Procedures…
    STAT · 1mo agoNeutral↗ source
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FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known…
fda press · 1mo agoApprovalPositive↗ source
  • Roche's Lunsumio clears Phase 3 hurdle, paving way for broader label in indolent lymphoma
    Roche announced that its T cell engager Lunsumio successfully met the primary endpoints in a Phase 3 study of a slow growing blood cancer. The trial, conducted in patients with indolent lymphoma,…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Orbis Medicines signs up to $1.4 billion partnership with Novo to develop macrocycle drugs for cardiometabolic disease
    Orbis Medicines, which is backed by Eli Lilly, announced a new collaboration with Novo focused on drug discovery. The agreement, valued at up to $1.4 billion, will target the creation of macrocycl…
    Endpoints · 1mo agoDealNeutral↗ source
  • England's NHS to fund AstraZeneca's Enhertu for metastatic breast cancer after U.K.-U.S. pricing pact
    English health authorities have agreed to provide AstraZeneca's breast cancer drug Enhertu through the NHS, ending a multi-year dispute over its availability. The decision will make the drug acces…
    STAT · 1mo agoDealPositive↗ source
  • FDA confronts surge of Chinese biotech firms as they become key industry players
    The FDA is currently assessing how to handle the rapid growth of biotech companies from China, which have moved from being economic competitors to important contributors in the pharmaceutical lands…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • UK parliamentary committees demand probe into cost of US-UK pharma trade deal
    Six UK parliamentary committees have written to the relevant watchdog asking for an investigation into the cost of the United Kingdom's pharmaceutical trade agreement with the United States. The c…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Michael J. Fox Foundation backs Ariadne Bio's non-hallucinogenic psychedelic for Parkinson's
    Ariadne Bio, a new biotech focused on Parkinson's disease, has received backing from the Michael J. Fox Foundation. The partnership centers on a non‑hallucinogenic psychedelic candidate that the fo…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA staffing shortage limits ability to hire new employees, raising concerns for health-care oversight
    STAT's D.C. Diagnosis newsletter reports that the FDA is experiencing a staffing bottleneck, with too few current employees to bring on additional hires. The shortage could slow the agency's capac…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Study finds purer fentanyl will not curb U.S. overdose deaths
    A new study highlighted that increasing the purity of fentanyl is unlikely to lower the number of overdose fatalities in the United States. Researchers noted that while purer fentanyl may be more…
    STAT · 1mo agoNegative↗ source
  • Sellas’ Phase 3 REGAL AML Immunotherapy Study Delayed, Forecast to Miss Survival Endpoint
    Sellas Life Sciences Group’s experimental immunotherapy galinpepimut‑S (GPS) is being tested in a Phase 3 REGAL trial for patients with acute myeloid leukemia in a second remission. The study has b…
    STAT · 1mo agoNegative↗ source
  • Researchers sue NIH over grant screening that they say violates First Amendment rights
    Researchers have filed a class action lawsuit against the National Institutes of Health, claiming the agency violates their First Amendment rights by searching grant applications for specific words…
    STAT · 1mo agoRegulatoryNegative↗ source
  • EU officials outline major pharmaceutical legislative reforms at RAPS Convergence 2026
    At RAPS Convergence 2026 in Charlotte, North Carolina, officials from the European Commission and the European Medicines Agency presented a set of reforms aimed at overhauling the European Union’s…
    raps · 1mo agoRegulatoryPositive↗ source
  • Bristol Myers ends $100M Phase 1 cancer ADC program
    Bristol Myers Squibb announced it has discontinued development of its Phase 1 antibody-drug conjugate candidate BMS-986497/ORM-6151. The decision follows a review of early clinical data, leading t…
    Endpoints · 1mo agoNegative↗ source
  • CMS offers Medicare pricing program exemptions to drugmakers who add Medicaid rebates
    The Centers for Medicare & Medicaid Services (CMS) has announced that drug manufacturers can be exempted from two Medicare pricing demonstration programs. The exemption is conditional on the compan…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Rare genetic variant linked to much higher lung cancer risk in never-smokers
    Researchers have discovered a very rare genetic variant that dramatically increases the odds of developing lung cancer among people who have never smoked. The study, published in Science, reports a…
    STAT · 1mo agoPositive↗ source
  • Cellares signs first Asian manufacturing deal with Taiwan's GenomeFrontier Therapeutics for CAR-T production
    Cellares announced a new partnership with Taiwanese biotech GenomeFrontier Therapeutics, marking the manufacturer’s first collaboration in Asia. The agreement will see Cellares evaluate and potenti…
    Endpoints · 1mo agoDealNeutral↗ source
  • Biotech hedge fund launches North Immunology to develop long-acting antibody for atopic dermatitis
    STAT+ hedge fund is creating a new immunology company called North Immunology with the goal of delivering a better, long-acting antibody therapy for atopic dermatitis. The concept originated two y…
    STAT · 1mo agoPositive↗ source
  • FDA hiring drive to add 2,000 staff stalls due to overwhelmed HR center
    The Food and Drug Administration says it plans to bring on more than 2,000 new employees, a move aimed at rebuilding staff after the 2025 cuts that eliminated about 3,500 positions. Agency officia…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Senate schedules hearing for FDA nominee as Novo teams with Anthropic on AI drug development
    The Senate has announced a hearing to consider the nominee for the next FDA commissioner, signaling a forthcoming review of the agency's leadership. In parallel, biotech firm Novo has entered a pa…
    raps · 1mo agoRegulatoryNeutral↗ source
  • CMS launches 10-year ACCESS health-tech pilot for Medicare
    CMS recently held an event to commemorate the summer launch of the ACCESS model, a decade-long pilot aimed at integrating health-technology solutions into Medicare. The program will test new digit…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Kennedy appoints eight specialists to U.S. Preventive Services Task Force, ending year-long vacancy
    Health secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force, filling vacancies after the panel had not met for more than a year. The appointees in…
    STAT · 1mo agoNeutral↗ source
  • Endpoints 11 reveals 2026’s most promising biotech startups at Boston gala
    The Endpoints editorial team announced the Endpoints 11 list, highlighting the most exciting biotech startups of 2026. The selection process involved months of research, interviews with executives,…
    Endpoints · 1mo agoNeutral↗ source
  • Startup launches trial of psychedelic-style drug for Parkinson’s symptom
    A new biotech startup announced it will begin preclinical testing of a psychedelic-like compound aimed at alleviating a specific symptom of Parkinson’s disease. The company plans to evaluate the d…
    STAT · 1mo agoNeutral↗ source