FDA Rejections, Explained: We Analyzed 200 CRLs for You
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…
UN Agencies Unveil Report on Leveraging AI in Traditional Medicine
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 Agree on Next Steps for Pandemic Agreement
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 President and CEO
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…
EU Approves TEVIMBRA® Plus Chemo as First-Line NPC Treatment
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 Sites Until 2030, Reaches Exit Deal for Frankfurt/Main
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, Stoke to Present Zorevunersen Dravet Syndrome Data at EPNS 2025
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 BRAVECTO® QUANTUM Injectable from Merck Animal Health
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®…
FDA Accepts Merck’s NDA for Once-Daily HIV-1 Treatment
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 Announce Exclusive Worldwide Licensing Deal for First-in-Class Trispecific Antibody ISB 2001
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…
EU Approves TEVIMBRA+Chemo for First-Line Nasopharyngeal Cancer
BeOne, a global oncology company, today announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with metastatic…
FDA Accepts Taiho’s Supplemental New Drug Application
FDA Accepts sNDA for INQOVI® Plus Venetoclax for Newly Diagnosed AML Patients Ineligible for Intensive ChemotherapyCombination therapy met primary efficacy endpoint with no new safety signals; would represent the first…