A Pew Charitable Trusts report says FDA should do more to deter businesses from selling stem cell interventions whose safety and effectiveness have no...
FDA accepts for priority review a BeiGene NDA for zanubrutinib for treating patients with mantle cell lymphoma who have received at least one prior th...
FDA clears a SurGenTec 510(k) for a neurostimulation indication for their Alara Neuro Access Needle Kit.
Indian active pharmaceutical ingredients maker Shilpa Medicare gets a five-observation Form FDA-483 after an inspection concluded 7/26.
21 physician organizations ask FDA not to finalize a guidance on insanitary conditions in drug compounding facilities in a way that would restrict the...
Federal Register notice: FDA determines that Sunovion Pharmaceuticals Zonegran (zonisamide) was not withdrawn for safety or effectiveness reasons.
President Donald Trump orders the Veterans Administration to obtain supplies of Johnson & Johnsons Spravato for use with suicidal veterans.
The HHS Inspection General says FDA is making progress in submitting clearance documents for FY 2015 and 2016 audit recommendations.