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 accelerated pathway for new drugs and ... Instead of waiting up to four years for NHS approval, the fast-track system could enable patients to benefit from such inventions much more quickly.
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.
(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 ...