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

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 ...

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.

Company Anticipates Submitting for U.S. Accelerated Approval in H1 2026 - WALTHAM, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular diseas ...

Analyst Michael Ulz of Morgan Stanley maintained a Buy rating on Dyne Therapeutics (DYN – Research Report), retaining the price target of ...

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

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 ...

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.

Cloud storage and file-sharing services play a crucial role in businesses of all sizes. Our top, tested picks can help your ...

The FDA has granted fast track designation to DYNE-101, a therapy for myotonic dystrophy type 1 (DM1) now in testing in a ...