The US FDA’s Center for Drug Evaluation and Research cleared two new molecular entities in the last days of September, both for rare diseases – intrahepatic cholangiocarcinoma for Taiho Pharmaceutical Co. Ltd.’s Lytgobi and amyotrophic lateral sclerosis for Amylyx Pharmaceuticals, Inc.’s Relyvrio.
Keeping Track: Orphans Headline FDA Approvals; Gene Therapies Stand Out Among Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
