Nasdaq

FDA Grants Priority Review for Biologics License Application (BLA) and EMA Accepts Marketing Authorisation Application (MAA) for Apitegromab as a Treatment for Spinal Muscular ...

Apitegromab Marketing Authorisation Application to the European Medicines Agency validated and under review The Company has also submitted and received validation for its Marketing Authorisation ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
JD Supra

FDA Announces Commissioner’s National Priority Voucher Program to Accelerate Drug Application Review Process and Support National Priorities

On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a new program that aims to speed up drug application review for ...