FDA places a clinical hold on a CRISPR Therapeutics and Vertex Pharmaceuticals trial of CTX001 for treating sickle cell disease pending the resolution...
FDA offers enhanced agency interactions to medical device manufacturers accepted in an innovation challenge to develop devices to help address the opi...
FDA clears a BrainCool 510(k) for the IQool Warm System, intended for use to provide thermal regulation to cool and rewarm adult patients when clinica...
FDA warns Australias Jalco Cosmetics about CGMP violations in its production of finished pharmaceuticals as a contract manufacturer.
FDA warns Chinas Jilin Shulan Synthetic Pharmaceutical Co. about CGMP deviations in its production of active pharmaceutical ingredients.
FDA accepts for priority review an Astellas Pharma NDA for gilteritinib for treating adult patients who have relapsed or refractory acute myeloid leuk...
FDA clarifies the submission process for expedited serious adverse event reports arising from ANDA BA/BE premarket studies.
FDA grants Pfizer a Breakthrough Therapy designation for Xalkori (crizotinib) for treating patients with metastatic non-small cell lung cancer who hav...