Cebranopadol

The FDA has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults, offering a novel multi-mechanistic approach.

Tris Pharma has reported positive Phase 3 trial results for cebranopadol in post-abdominoplasty pain management, demonstrating significant pain reduction compared to placebo. The success positions the company to compete with Vertex in the acute pain market, with plans for regulatory submission later this year.

The FDA approved Madrigal's Rezdiffra, the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), addressing a significant unmet need in liver disease.

The FDA has approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for treating moderate to severe acute pain in adults, offering a safer alternative to opioids.

The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.