FDA releases its latest batch of Warning Letters that includes Cipla Limited, Gojo Industries and Windlas Healthcare Private Limited.
Novo Nordisk stops two clinical trials in its concizumab Phase 3 development program and one clinical trial in the Phase 2 program due to safety issue...
FDA adds three questions to its FAQs on developing Covid-19 diagnostics.
FDA approves safety labeling changes for four SGLT2 inhibitors to recommend that their use be temporarily discontinued several days before planned sur...
Federal Register notice: FDA makes available a final guidance on drugs for slowly progressive, low-prevalence rare diseases with substrate deposition.
Federal Register notice: FDA extends the comment period on a draft guidance entitled Drug Products Labeled as Homeopathic.
Federal Register notice: FDA makes available a final guidance entitled Competitive Generic Therapies.
Former FDA commissioner Scott Gottlieb says that with new approved testing coming online the U.S. will be in good shape for coronavirus testing by the...