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  • Merck touts promising ADC sacituzumab tirumotecan as potential cornerstone therapy at ASCO
    Merck highlighted a new antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), licensed from Chinese biotech Kelun-Biotech, at the ASCO meeting. The company said early clinical data have give…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Positive data from Bristol Myers in multiple myeloma and Pfizer in lung cancer unveiled at ASCO
    At the American Society of Clinical Oncology (ASCO) meeting, Bristol Myers Squibb presented early-stage results that showed a favorable response in a multiple myeloma trial. The data suggest the in…
    STAT · 3mo agoPositive readoutPositive↗ source
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  • Trump administration proposes overhaul of federal grant rules, sparking researcher concerns
    The White House released a more than 400-page proposal that would rewrite the core regulation governing all federal grants. The administration says the changes are meant to curb waste and increase…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Replimune to file third FDA application for RP1 cancer therapy after productive talks
    Replimune announced it will submit a third marketing application for its experimental cancer therapy RP1, following what the company described as productive discussions with the Food and Drug Admin…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Allogene CEO David Chang to step down as Agios drug misses mid-stage trial results
    Allogene announced that its chief executive, co‑founder David Chang, will leave the role after an eight‑year tenure. Chang, who previously worked at Kite Pharma, will remain on the company’s board…
    BioPharma Dive · 3mo agoNegative readoutNeutral↗ source
  • Former FDA official says leadership turnover won’t derail push for faster US drug trials
    The Food and Drug Administration has faced a wave of leadership changes this year, creating uncertainty about its ability to keep drug development moving quickly. Industry leaders and regulators, h…
    BioPharma Dive · 3mo 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 · 3mo agoRegulatoryNegative↗ source
  • 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoRegulatoryNegative↗ 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
  • 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 and Ionis report functional cure in 20% of hepatitis B patients with bepirovirsen in early trials
    GSK and Ionis disclosed results from two clinical studies of their RNA‑based injection, bepirovirsen, aimed at achieving a functional cure for chronic hepatitis B. In both trials about one‑fifth o…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • CVS adds Lilly’s Foundayo and Zepbound to formularies, leveling GLP-1 market with Novo
    CVS Caremark announced it will place Eli Lilly’s new oral GLP-1 drug Foundayo on its formulary starting June 1 and will restore the injectable Zepbound as a preferred option from Oct 1. The change…
    BioPharma Dive · 3mo agoDealPositive↗ 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
  • 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
  • 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
  • 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