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3,277 stories matching this filter · ← front page

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  • U.S. policy bars Ebola patients from entering country, plans overseas evacuation
    U.S. health officials announced that any American who contracts Ebola will not be taken to the United States for care. Instead, patients will be moved to undisclosed locations in Europe for treatme…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Niowave breaks ground on $75M radioisotope plant in Michigan; CordenPharma to acquire AmbioPharm
    Niowave announced it has started construction of a new radioisotope production facility in Lansing, Michigan, with an investment of about $75 million. The plant will produce radioisotopes used in…
    Endpoints · 3mo agoDealNeutral↗ source
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  • Charles River CEO predicts more manufacturers will spin off cell and gene therapy units
    Charles River Laboratories announced three months ago that it would divest its manufacturing unit dedicated to cell and gene therapy production. CEO Birgit Girshick said the company expects it wil…
    Endpoints · 3mo agoNeutral↗ source
  • China gene-editing startup YolTech secures $70 million funding ahead of Hong Kong IPO plans
    YolTech Therapeutics, a Chinese company focused on CRISPR gene-editing therapies, announced it has closed a $70 million financing round, the largest in its history. The capital will be used to adv…
    Endpoints · 3mo agoDealPositive↗ source
  • Oura expands into health services with launch of smaller Ring 5 wearable
    Oura announced the release of its new Ring 5, a smaller version of its popular health‑tracking ring. Alongside the hardware launch, the company said it will add features that let users link their…
    Endpoints · 3mo agoPositive↗ source
  • Former Legend Biotech co‑founder Frank Fan launches new venture at Wondercel Therapeutics
    Frank Fan, a co‑founder of Legend Biotech, moved from Nanjing to Shenzhen in 2022 in search of a fresh start. After leaving Legend abruptly, he assumed the role of chief executive officer at Wonde…
    Endpoints · 3mo agoPositive↗ source
  • FDA delays AstraZeneca breast cancer drug camizestrant PDUFA date
    The U.S. Food and Drug Administration has extended the PDUFA target date for AstraZeneca’s breast cancer candidate camizestrant, pushing the review timeline back by a few days. No new deadline was…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • 23andMe partners with HealthEx to let users import medical records for a 360-degree health view
    23andMe announced a partnership with HealthEx that will let its customers import their medical records, creating a more complete view of personal health. The new feature will combine genetic data…
    STAT · 3mo agoDealPositive↗ source
  • Supreme Court refuses to hear pharma challenges to Medicare price negotiation program
    The U.S. Supreme Court declined to review lawsuits filed by several brand‑name drug makers against the Medicare drug price negotiation program, dealing a significant setback to the industry. The c…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Mentari Therapeutics to go public via reverse merger with InMed, raising $290 million for migraine antibody programs
    Mentari Therapeutics, a spinout of Paragon, announced a reverse merger with InMed Pharmaceuticals that will take the company public under the Mentari name. The deal has received board approval fro…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Virginia Governor Vetoes Bill to Create Drug-Cost Advisory Panel Using Medicare Benchmarks
    Virginia's governor, Abigail Spanberger, vetoed a bill that would have created a new advisory panel aimed at lowering prescription-drug costs. The legislation had been closely watched as a potentia…
    STAT · 3mo agoRegulatoryNegative↗ source
  • AI tool guides Mayo clinicians to rapid treatment for newborn with ultra-rare disease
    An AI system called the Biomedical Data Translator was used by doctors at the Mayo Clinic to search for a therapy for a newborn with an ultra-rare disease. The infant, Jorie Kraus, was born with s…
    STAT · 3mo agoPositive↗ source
  • Acceleron veterans and Westlake back new IPF biotech Oorja Bio with $30 million Series A
    Entrepreneurs who previously brought the drug Winrevair to market have launched a new biotech, Oorja Bio, to target idiopathic pulmonary fibrosis, a hard-to-treat lung disease. The company announc…
    Endpoints · 3mo agoDealPositive↗ source
  • Former FDA commissioner sees hope for stability under new acting leader Kyle Diamantas
    At a recent STAT Breakthrough Summit West, former FDA commissioner David Kessler addressed concerns about the agency’s recent turmoil and staff departures. Kessler said the appointment of acting c…
    STAT · 3mo agoRegulatoryPositive↗ source
  • BioMarin's BMN-401 fails key endpoint in ENPP1 deficiency Phase 3 trial
    An experimental therapy, BMN 401, was tested in a Phase 3 study for ENPP1 deficiency, a rare disease. The drug missed one of its two co-primary endpoints, a result that regulators consider critical…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • Novo Nordisk streamlines R&D to speed discovery, adds AI to integrated research teams
    Novo Nordisk's new CEO Maziar Mike Doustdar, who took the helm in the summer of 2025, announced a reorganization of the company's R&D structure. Jacob Sten Petersen, head of global research, expla…
    Endpoints · 3mo agoPositive↗ source
  • Full-Life Technologies secures $150M Series D financing
    Full-Life Technologies announced it has raised $150 million in a Series D financing round, comprising $110 million in the main tranche and an additional $40 million. The capital is intended to adv…
    Endpoints · 3mo agoDealNeutral↗ source
  • Relay Therapeutics reports promising Phase 2 results for zovegalisib; Eli Lilly leads R&D performance ranking
    Relay Therapeutics announced positive Phase 2 data for its experimental drug zovegalisib, which targets rare diseases that cause abnormal blood vessel development. The company said the results were…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Relay Therapeutics' zovegalisib shows 60% response in mid‑stage trial for rare vascular anomalies
    Relay Therapeutics reported early data from a phase 2 trial of its experimental drug zovegalisib in patients with vascular anomalies, a group of rare disorders characterized by abnormal blood vesse…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Eli Lilly Leads Both Innovation and Invention Rankings in Pharma R&D Performance
    STAT+ reports that Eli Lilly captured the top positions in a prominent pharma R&D performance ranking, leading both the innovation and invention categories. The rankings, compiled by UK-based IDEA…
    STAT · 3mo agoPositive↗ source
  • Relay Therapeutics' zovegalisib meets efficacy endpoint in Phase 2 vascular anomalies trial
    Relay Therapeutics reported that its PI3Kα inhibitor zovegalisib achieved the predefined efficacy threshold in a Phase 2 study of a rare genetic vascular anomaly. The data readout exceeded Wall Str…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • BioMarin's Phase 3 trial of ENPP1 enzyme therapy fails to show benefit
    BioMarin reported that its late-stage study of an enzyme replacement therapy for ENPP1 deficiency did not meet its primary efficacy endpoints. The trial, which enrolled patients lacking the ENPP1 e…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Over 1 in 8 U.S. Pregnant Women Report Alcohol Use, Raising Fetal Health Concerns
    More than one in eight pregnant adults in the United States reported drinking in the past month, according to STAT's analysis of 2024 government data, making alcohol use more common than gestationa…
    STAT · 3mo agoNegative↗ source
  • UK adopts tobacco-free generation law, mirroring Massachusetts policy
    The United Kingdom has passed a tobacco‑free generation law that bars retailers from selling cigarettes, vapes or nicotine pouches to anyone born on or after Jan. 1, 2009. Existing customers may co…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Heart transplant patient warns of 'ghost approval' gap that leaves life-saving drugs out of reach
    A heart transplant recipient and patient advocate describes how the medication everolimus (Zortress) is essential to prevent organ rejection, not an optional treatment. The author coins the term "…
    STAT · 3mo agoNegative↗ source