Hemogenyx Pharmaceuticals files its complete response to an FDA HEMO-CAR-T clinical hold in hopes of starting Phase 1 trials.
FDA publishes the summary of an October 2023 public meeting on continuing the Covid-19 lessons learned for modernization and innovation in clinical tr...
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.
