Fast track for Moderna’s novel coronavirus vaccine
The move could help accelerate the development and review of the mRNA vaccine candidate
Read More
Tag: Fast Track
FDA Fast Track granted for AZ’ Forxiga
The indication, chronic kidney disease, is a serious, progressive condition defined by decreased kidney function.
Read More
Shire’s rare blood disorder drug gets US fast track
An experimental therapy in development by Shire for patients with the rare blood disorder hereditary thrombotic thrombocytopenic purpura (hTTP) has been granted a fast track designation by the US Food and Drug Administration.
Read More
US fast track for Shire’s liver drug
US regulators have placed Shire’s SHP626 on a fast-track regulatory pathway in the hope of potentially accelerating access to the experimental liver disease drug.
Read More
- Kahimmune Therapeutics enters licensing agreement with Gustave Roussy and SATT Paris-Saclay
- IBSA UK&I launches Perovial for the treatment of acute Peyronie’s disease
- En Carta Diagnostics’ EC Pocket Lyme test receives FDA Breakthrough Device Designation
- ALK’s EURneffy receives positive CHMP opinion for emergency anaphylaxis treatment in children
- CERo reports encouraging early data from phase 1 trial of CER‑1236
