Capricor Shares Tumble After FDA Rejects Cell Therapy for Duchenne Cardiomyopathy Over Efficacy Concerns Capricor Therapeutics suffered a major regulatory setback Friday after the U.S. Food and Drug Administration (FDA)…
Moderna Secures Full FDA Approval for Spikevax in High-Risk Children Amid Growing mRNA Scrutiny Moderna has scored another key regulatory milestone as the U.S. Food and Drug Administration (FDA) granted…
The FDA’s surprise release of 200 complete response letters (CRLs) offered a rare glimpse into the inner workings of the agency’s decision-making—and the winding paths some drugs took to eventually…
AI Meets Ancient Wisdom: UN Agencies Launch Report on Artificial Intelligence in Traditional Medicine Artificial intelligence (AI) is opening new frontiers for traditional medicine, combining centuries-old healing practices with cutting-edge…
WHO Member States Convene First IGWG Meeting, Set Roadmap for Implementing Pandemic Agreement In a significant step toward bolstering global health security, World Health Organization (WHO) Member States gathered for…
Jazz Pharmaceuticals Appoints Renee Gala as Chief Executive Officer, Marking a New Chapter in Company’s Growth Strategy Pharmaceuticals today announced a significant leadership transition that marks a pivotal moment in…
European Commission Approves TEVIMBRA® (Tislelizumab) with Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma BeOne Medicines Ltd., a global biotechnology company dedicated to oncology innovation, today announced that…
Bayer Secures German Operations Until 2030 with New Agreement, Plans Structured Exit from Frankfurt Site In a significant development for its workforce and long-term operational strategy in Germany, Bayer AG…
Biogen and Stoke Present New Zorevunersen Data Supporting Phase 3 Dravet Syndrome Study Biogen and Stoke Therapeutics, Inc. (Nasdaq: STOK) today presented new data supporting the design and dosing strategy…
FDA Approves Merck Animal Health’s BRAVECTO® QUANTUM, a Year-Long Injectable Flea and Tick Treatment for Dogs Merck Animal Health, a division of Merck & Co., announced FDA approval of BRAVECTO®…
Merck’s NDA for Once-Daily Doravirine/Islatravir HIV Regimen Accepted by U.S. FDA Merck, known as MSD outside the U.S. and Canada, announced that the U.S. Food and Drug Administration (FDA) has…
AbbVie and IGI Therapeutics Sign Exclusive Global Licensing Agreement for Trispecific Antibody ISB 2001 AbbVie and IGI Therapeutics SA, a wholly owned subsidiary of Ichnos Glenmark Innovation, Inc. (IGI), today…