A month after gaining FDA approval for treating sickle cell disease with the gene therapy Casgevy, Vertex secures its second approval for treating tra...
Federal Register notice: FDA announces the approval of a product that redeemed a material threat medical countermeasure priority review voucher Novar...
FDA alerts patients and healthcare providers about Exactechs Equinoxe Shoulder System joint replacement devices and possible health risks.
ROi CPS recalls its Regard Operative Lap P&S Surgical Kit due to sterility concerns.
FDA grants Hyloris Pharmaceuticals an orphan drug designation for PTX-252 for treating acute myeloid leukemia.
Reps. Matsui and Buschon introduce bipartisan legislation they say will help the federal government anticipate and mitigate drug shortages.
Attorney Chia-Feng Lu sees increasing FDA interest in guidance on and enforcement of off-label communications.
The DC federal court approves a six-month stay in FDAs records production for an FOIA request from Childrens Health Defense for records related to Cov...
