FDA Flags Potential NAION Vision‑Loss Risk with GLP‑1 RA Medications – Labeling Update Required Across the Drug Class
The U.S. Food and Drug Administration (FDA) announced it is informing patients and health care providers of a potential increased risk of non‑arteritic anterior ischemic optic neuropathy (NAION) associated with…
Immunochina’s IM19 Wins NMPA Approval – First Fully In‑House CD19 CAR‑T Cell Therapy for Relapsed or Refractory Large B‑Cell Lymphoma in China
Immunochina Pharmaceuticals, a Beijing‑based biotech, announced that its first fully in‑house developed, CD19‑targeted autologous CAR‑T cell therapy, IM19 CAR‑T Cell (development code: IM19), has been approved for marketing by China's National Medical Products Administration (NMPA) for the treatment of adult…
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Charles River to Acquire Frontage’s Bioanalysis and DMPK Operations for ~$470 Million – Expanding Early-Phase Laboratory Footprint in Exton, Pennsylvania
Charles River Laboratories International, Inc. (NYSE: CRL) announced that it will acquire the bioanalysis and DMPK (drug metabolism and pharmacokinetics) operations of Frontage Holdings Corporation (HKG: 1521), based in Exton,…
NMPA Proposes Drug Market Exclusivity Framework – Up to Seven Years for Rare Disease Therapies and Two Years for Pediatric Drugs
The Comprehensive Department of China's National Medical Products Administration (NMPA) has released the Measures for the Implementation of Drug Market Exclusivity (Draft for Comment), proposing a unified exclusivity regime that…
