FiercePharma1d
PTC wins FDA approval for first brain-delivered gene therapy Kebilidi
The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy ...
pharmaphorum17d
Novartis gets FDA okay for frontline use of Scemblix in CML
The new accelerated approval covers the use of Scemblix for newly diagnosed patients with Philadelphia chromosome-positive ...
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 ...