Two Dominican High-Cost Lists Overlap by Only 44 Products. FOMAC Would Be a Third.
The country already covers this. Two schemes list 120 and 115 high-cost medicines, overlapping by 44. FOMAC would be a third list, starting at 13.
Spinal muscular atrophy
Scholar Rock Filed With Two Fill-Finish Sites. One Just Failed, and the Date Held.
Catalent Indiana failed its FDA inspection. Scholar Rock had named a second fill-finish site in the same BLA, so the PDUFA date did not move.