image credit: Adobe Stock

5 FDA decisions to watch in the second quarter

April 3, 2023


Over the next three months, the Food and Drug Administration could approve the first vaccines for an elusive virus, the first gene therapy for a deadly neuromuscular disorder and a new treatment for a genetic form of ALS.

Each decision is important in its own right, but each could also have broader implications for the biotech and pharmaceutical sector.

Respiratory syncytial virus, or RSV, has bedeviled researchers for years and the fact that vaccines are now in reach represents a scientific step forward that could buoy other efforts. Sarepta Therapeutics’ gene therapy for Duchenne is the culmination of a long biotech journey and the FDA’s verdict on it will be suggestive of broader agency views on similar therapies. An approval for Biogen’s drug tofersen, meanwhile, could set a precedent that other developers of ALS medicines seek to follow.

Read More on Biopharma Dive