Several biotech companies await FDA decisions in August 2026 across indications including ultra-rare Fibrodysplasia Ossificans Progressiva, melanoma, Alzheimer's disease, multiple myeloma, Duchenne muscular dystrophy, Glycogen Storage Disease, HIV, and essential thrombocythemia. The FDA has approved 29 novel drugs so far in 2026, ahead of the 21 approvals during the same period in 2025, when a total of 46 novel drugs were approved. In July, the FDA approved Vertex Pharmaceuticals' Casgevy as the first gene therapy for young children with sickle cell disease, Merck's Lipfendra as the first oral PCSK9 inhibitor for adults with hypercholesterolemia, and Ezplaz Freeze-Dried Plasma as the first freeze-dried plasma product for transfusion when conventional plasma is unavailable.
Bristol-Myers Squibb Company
Capricor Therapeutics Inc
Gilead Sciences Inc
Lantheus Holdings Inc
Merck & Company Inc
Moderna Inc
Regeneron Pharmaceuticals Inc
Replimune Group Inc
Vertex Pharmaceuticals Inc
Merck KGaA