FDA grants Eli Lilly an emergency use authorization for its investigational monoclonal antibody therapy bamlanivimab for treating of mild-to-moderate ...
FDA warns Mexicos Nartex Laboratories about CGMP violations in its production of finished drugs.
Amgen and AstraZeneca say their investigational asthma drug tezepelumab achieved positive results in the Phase 3 NAVIGATOR trial.
Sens. Warren and Smith ask FDA for information on what it needs to adequately conduct foreign drug inspections during the pandemic.
Federal Register notice: FDA makes available a revised final guidance on Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017....
Federal Register notice: FDA makes available a final guidance entitled Regulatory Considerations for Microneedling Products.
Federal Register notice: FDA makes available a final guidance entitled Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, En...
Supernus Pharmaceuticals says it has received a complete response letter and refusal to file letter from FDA for two NDAs and will seek agency guidanc...