A new report from HHS' Office of Inspector General raises concerns about the FDA's accelerated approval process for drugs with weak supporting evidence, Bloomberg reported Jan. 14. The report ...

The U.S. Securities and Exchange Commission (SEC) has granted fast-track approval for Bitwise’s spot Bitcoin (BTC) and ...

This may lead to earlier drug approval and access by patients. A drug receiving Fast Track designation also may be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

Dyne Therapeutics received fast-track designation from the Food and Drug Administration for a treatment of myotonic dystrophy type 1, a neuromuscular disease.

Companies with fast-track designations can secure the FDA’s accelerated approval and priority review, subject to conditions, allowing them faster market access. More on Candel, Edgewise ...

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer ... Such therapeutics could also be eligible to receive accelerated approval and priority review if they ...

(RTTNews) - Dyne Therapeutics, Inc. (DYN), Tuesday announced that the U.S. Food and Drug Administration has granted Fast Track designation for DYNE-101 for the treatment of myotonic dystrophy type 1, ...

The US Securities and Exchange Commission (SEC) has given initial approval for Bitwise’s spot Bitcoin (BTC) and Ethereum (ETH) Exchange-Traded Fund (ETF). The SEC confirmed that the filing received ...