BioPharma Dive January 9, 2023
An Alzheimer’s drug, a hemophilia gene therapy and two breast cancer drugs are among the top decisions on the agency’s docket through the end of March.
The downturn that struck the biotechnology industry in 2022 wasn’t just about tumbling stock prices. The sector also won only 37 new drug approvals from the Food and Drug Administration’s main review office last year, its lowest total since 2016.
Yet the number of drugs the FDA clears each year can fluctuate, and industry observers see reasons for optimism. The 2022 approvals of Amylyx Pharmaceuticals’ ALS drug and Provention Bio’s Type 1 diabetes treatment show an “increasing permissiveness” for drugs with mixed or limited data, RBC Capital Markets analysts wrote in December. Drug rejections...
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