GlobalData on MSN17d
Novartis’ Scemblix gains FDA approval for leukaemia
Novartis has received US Food and Drug Administration (FDA) accelerated approval for Scemblix (asciminib) to treat adults ...
Monthly Prescribing Reference11d
FDA Drug Approval Decisions Expected in December 2024
If approved, sotagliflozin would be the first oral medication for patients with T1D. The FDA is reviewing the BLA for datopotamab deruxtecan (Dato-DXd), a specifically engineered TROP2-directed DXd ...
News Medical2d
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous ...
FiercePharma3d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...