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  • FDA approves Revolution Medicines' Rasonque for metastatic pancreatic cancer
    Revolution Medicines received FDA approval for its oral RAS inhibitor daraxonrasib, branded as Rasonque, to treat patients with metastatic pancreatic adenocarcinoma who have already received prior…
    Fierce Biotech · 13h agoApprovalPositive↗ source
  • FDA grants rapid approval to Revolution Medicines' pancreatic cancer drug Rasonque
    FDA approved Revolution Medicines' pancreatic cancer therapy Rasonque, just over a month after submission using a priority review voucher. The drug, formerly known as daraxonrasib, is for patients…
    BioPharma Dive · 7h agoApprovalPositive↗ source
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  • FDA approves Rasonque, first therapy targeting genetic cause of advanced pancreatic cancer
    The U.S. Food and Drug Administration has granted approval to Rasonque, a drug from Revolution Medicines, for patients with advanced pancreatic cancer. The medicine, whose generic name is daraxonra…
    STAT · 10h agoApprovalPositive↗ source
  • Biohaven sells rights to its lead epilepsy drug opakalim to SK Biopharma for up to $795 million
    Biohaven announced it will transfer the rights to its most advanced experimental therapy for focal epilepsy, known as opakalim, to South Korean company SK Biopharma. The agreement could bring as m…
    BioPharma Dive · 10h agoDealNeutral↗ source
  • FDA approves Revolution Medicines' daraxonrasib for second-line pancreatic cancer
    The U.S. Food and Drug Administration announced approval of Revolution Medicines' drug daraxonrasib for patients with pancreatic cancer who have already received prior therapy. The approval marks…
    Endpoints · 10h agoApprovalPositive↗ source
  • Experimental drugs to lower Lp(a) move toward market, promising billions in potential sales
    High levels of lipoprotein(a), or Lp(a), are a genetic risk factor for heart disease that affects roughly one in five people and currently has no approved therapy. Several drugmakers are moving ex…
    STAT · 16h agoPositive↗ source
  • Spyre shares plunge as rheumatoid arthritis trial of SPY072 falls short of internal target
    Spyre Therapeutics reported that its antibody SPY072 did not meet the company’s internal criteria in a mid‑stage rheumatoid arthritis trial, despite showing some activity. The placebo‑controlled s…
    BioPharma Dive · 8h agoNegative readoutNegative↗ source
  • Biohaven secures up to $795 million partnership with SK Biopharma for global epilepsy drug rights
    Biohaven announced a commercial partnership for its late-stage epilepsy program. South Korea-based SK Biopharma has agreed to pay up to $795 million for worldwide rights to the company's Kv7 ion ch…
    Endpoints · 8h agoDealPositive↗ source
  • Hansoh says China’s biopharma is shifting from follower to frontrunner, now behind 30% of investigational drugs
    Hansoh Pharmaceutical used its first‑half earnings release to claim that China’s innovative biopharma sector is moving from a follower role to a frontrunner position. The company highlighted that…
    Fierce Biotech · 15h agoEarningsPositive↗ source
  • Spyre Therapeutics cuts rheumatoid arthritis program after weak Phase 2 TL1A antibody results
    Spyre Therapeutics reported that its Phase 2 study of the anti‑TL1A antibody SPY072 in rheumatoid arthritis did not meet the efficacy expectations set earlier this year. The company said the data f…
    Fierce Biotech · 19h agoNegative readoutNegative↗ source
  • MassBio CEO warns 2025 may be biotech's toughest year amid China and NIH challenges
    Massachusetts is widely regarded as the epicenter of biotech because of its world‑class research institutions and vibrant startup ecosystem. MassBio CEO Kendalle Burlin O’Connell said 2025 will pr…
    Endpoints · 7h agoNegative↗ source
  • Haisco licenses inflammatory disease candidate to US startup Sentivera; ViiV's HIV drug cleared for newborns
    Haisco Pharmaceutical announced that it has granted a license to US biotech Sentivera for the ex‑China rights to an unnamed inflammatory‑disease candidate. The agreement gives Sentivera the ability…
    Endpoints · 10h agoDealNeutral↗ source
  • Aurora Therapeutics halts lead CRISPR program and cuts staff
    Aurora Therapeutics, founded as the first company dedicated to developing custom CRISPR-based gene-editing medicines, announced a major restructuring. The firm said it is laying off several employ…
    Endpoints · 10h agoLayoffsNegative↗ source
  • Study finds Lilly's obesity drug Zepbound may lower hospital and ER costs for older adults
    A real‑world analysis examined older patients with obesity or excess weight who were either treated with Eli Lilly’s drug Zepbound or not. The researchers tracked healthcare utilization over time t…
    BioPharma Dive · 11h agoPositive readoutPositive↗ source
  • U.S. Employers Plan to Drop GLP-1 Drug Coverage, Survey Shows 14% Will Cut Benefits by 2027
    About 14% of U.S. employers have already decided or intend to stop covering GLP-1 medicines by 2027, according to a Reuters‑cited Business Group on Health survey. The shift reflects growing concern…
    STAT · 12h agoNegative↗ source
  • Akeso and Summit report ivonescimab meets primary endpoint in China Phase 3 biliary tract cancer trial
    Akeso Therapeutics and partner Summit Therapeutics announced that their bispecific antibody ivonescimab achieved the primary efficacy endpoint in a Phase 3 study conducted exclusively in China. Th…
    Endpoints · 14h agoPositive readoutPositive↗ source
  • Faro AI secures $37M Series B to accelerate clinical trials with artificial intelligence
    Faro AI, a San Diego‑based startup, announced a $37 million Series B financing round aimed at expanding its artificial‑intelligence platform. The new funding will be directed toward developing too…
    Endpoints · 14h agoDealPositive↗ source
  • Akeso reports phase 3 overall survival win for ivonescimab in advanced biliary tract cancer
    Akeso announced that its bispecific antibody ivonescimab combined with chemotherapy improved overall survival in a China phase 3 trial for advanced biliary tract cancer, beating the standard regime…
    Fierce Biotech · 14h agoPositive readoutPositive↗ source
  • Profit motive highlighted as key to advancing women’s health research and boosting economic productivity
    Experts say that turning to the profit motive could spur investment in under‑funded women’s health areas such as endometriosis, osteoporosis and autoimmune disorders. They note a long history of r…
    STAT · 16h agoNeutral↗ source
  • FDA clears Abbott’s Libre Duo 10-Day sensor to warn of diabetic ketoacidosis
    The U.S. Food and Drug Administration has cleared Abbott’s new wearable device that measures both glucose and ketone levels in people with diabetes. The clearance allows the product to be marketed…
    Fierce Biotech · 16h agoApprovalPositive↗ source
  • Boston Scientific reports cyberattack that disrupts operations and order processing
    Boston Scientific disclosed in an SEC filing on Aug. 26 that it detected a cybersecurity incident the previous day, marking the latest medtech cyberattack of the year. The breach impacted several…
    Fierce Biotech · 17h agoNegative↗ source
  • Kennedy spreads vaccine misinformation as measles deaths spark heated call with Pennsylvania governor
    After Pennsylvania health officials reported two deaths among unvaccinated individuals from measles, HHS Secretary Robert F. Kennedy Jr. phoned Governor Josh Shapiro to discuss federal assistance.…
    STAT · 7h agoNegative↗ source
  • Key data on lipoprotein(a)-targeting cardiovascular drugs expected soon
    A STAT+ newsletter highlights that several major pharmaceutical firms are developing drugs that lower lipoprotein(a), a particle linked to heart disease. The companies view Lp(a) reduction as a po…
    STAT · 10h agoNeutral↗ source
  • Insitro CEO Daphne Koller discusses using AI to accelerate clinical trials
    STAT+ AI Prognosis newsletter featured an interview with Insitro chief executive Daphne Koller about the role of artificial intelligence in drug discovery and how it could speed up clinical trials.…
    STAT · 11h agoNeutral↗ source
  • Two Unvaccinated Pennsylvania Residents Die from Measles, First US Measles Deaths in 2026
    The Pennsylvania Department of Health reported two measles-associated deaths in the state. Both individuals were unvaccinated, making these the first measles deaths in the United States for 2026 an…
    STAT · 11h agoNeutral↗ source