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  • FDA releases draft guidance to trim animal testing in cancer drug development
    The FDA's Oncology Center of Excellence announced a draft guidance aimed at reducing unnecessary animal studies in the nonclinical safety assessment of certain oncology drugs. The guidance suggest…
    fda press · 5mo agoRegulatoryPositive↗ source
  • US says Ebola patients will be evacuated to Europe, not treated in America, as outbreak grows
    The World Health Organization is reviewing which vaccines could help curb the expanding Ebola outbreak in Africa. The U.S. government announced it will no longer bring Americans infected with Ebol…
    STAT · 5mo agoRegulatoryNegative↗ source
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  • XPRIZE Healthspan launches $101 million competition to test anti-aging therapies in older adults
    Jamie Justice, former Wake Forest professor, now leads XPRIZE Healthspan, a global contest aimed at finding treatments that can restore muscle, cognition and immune function in older people. The c…
    STAT · 5mo agoPositive↗ source
  • Replimune seeks third FDA approval attempt, Pfizer signs China deal, panel backs updated Covid vaccine
    Replimune is pursuing a third attempt to secure FDA approval for its investigational therapy, after two prior submissions did not succeed. Pfizer has entered into a new agreement to expand its pre…
    STAT · 5mo agoNeutral↗ source
  • Allogene announces CEO David Chang will step down
    Allogene Therapeutics disclosed that its chief executive, David Chang, will be leaving the company. The firm indicated that a succession plan is in place, though it did not provide a specific timel…
    STAT · 5mo agoNeutral↗ source
  • Massachusetts sues UnitedHealth over alleged Medicaid fraud targeting seniors
    Massachusetts Attorney General Andrea Joy Campbell filed a lawsuit against UnitedHealth Group's UnitedHealthcare subsidiary, alleging the insurer deliberately over‑coded health conditions of low‑in…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Allogene CEO David Chang to step down after eight years; former Esperion chief joins Phlow
    Longtime Allogene chief executive David Chang announced he will leave the role at the end of June, concluding an eight‑year tenure leading the cell‑therapy developer. The company said a successor…
    Endpoints · 5mo agoNeutral↗ source
  • 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 · 5mo 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 · 5mo agoRegulatoryNegative↗ source
  • 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo agoRegulatoryNeutral↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 5mo agoApprovalPositive↗ source
  • FDA issues warning letters to eight retailers for selling unauthorized tobacco products that mimic candy and other everyday items
    The U.S. Food and Drug Administration announced on May 20, 2026 that it has sent warning letters to eight retailers for offering unauthorized nicotine pouches and dissolvable tobacco products that…
    fda press · 5mo agoRegulatoryNegative↗ source