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  • Replimune to resubmit melanoma therapy RP1 to FDA after two prior rejections
    Replimune announced on Friday that it will again submit its advanced melanoma candidate, RP1, to the U.S. Food and Drug Administration for review. The company says the filing follows new discussion…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Kenyan court halts U.S. plan for Ebola quarantine facility for Americans
    A Nairobi High Court on Friday ordered a stop to a U.S. proposal to build a quarantine center in Kenya for Americans who might have been exposed to a rare Ebola strain circulating in northeastern C…
    STAT · 3mo agoRegulatoryNegative↗ source
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  • Weight-loss doctor warns against unproven GLP-1 microdosing for cosmetic use
    Dr. Jody Dushay, a Harvard‑affiliated weight‑loss specialist, says patients are asking about tiny doses of GLP‑1 drugs for cosmetic slimming. She notes there is no scientific definition of “microd…
    STAT · 3mo agoNegative↗ source
  • GC Therapeutics appoints former BlueRock executive Stefan Irion as chief scientific officer
    GC Therapeutics announced that Stefan Irion has joined the company as its new chief scientific officer. Irion previously served in the same capacity at BlueRock Therapeutics. Irion brings experien…
    STAT · 3mo agoNeutral↗ source
  • GSK reports strong Phase 3 results for Ionis-licensed chronic hepatitis B therapy
    GSK disclosed data from two late‑stage trials of a chronic hepatitis B treatment it licensed from Ionis Pharmaceuticals. The studies evaluated the drug’s efficacy and safety in patients with chroni…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Eli Lilly's obesity drugs Foundayo and Zepbound added to CVS Caremark formulary
    Eli Lilly announced that its two flagship obesity treatments, the oral agent Foundayo and the injectable Zepbound, will be listed on CVS Caremark's drug formularies. The inclusion comes as the GLP…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • AbbVie receives FDA approval for ultra-rare blood cancer ADC acquired from ImmunoGen
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for an antibody-drug conjugate targeting an ultra-rare, aggressive form of blood cancer. The therapy was obtained t…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Signos secures $20 million to advance GLP-1-focused wearable platform amid broader wearables interest
    The article notes that two wearable‑related developments are being discussed, and both involve GLP‑1 therapies. Signos announced it has raised $20 million to fund its approach that combines wearab…
    Endpoints · 3mo agoDealPositive↗ source
  • ICON audit reveals $65.3M and $92.7M revenue overstatements; Secretome and Psilera announce cash raises
    ICON completed an internal audit that confirmed its reported revenue had been overstated. The audit quantified the overstatement at $65.3 million for 2023, representing about 0.8% of that year's t…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • 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
  • 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
  • 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
  • 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