FDA approves a Med-EL USA PMA supplement for the slim and lightweight Rondo 3 Audio Processor for use with its Synchrony Cochlear Implant.
Federal Register notice: FDA announces a 10/22 Patient Engagement Advisory Committee meeting.
FDA posts final determinations for three drugs under the drug efficacy study implementation program.
FDA publishes a draft guidance on designing clinical trials for cancer drugs in patients with central nervous system metastases.
FDA accepts for priority review an EMD Serono NDA for once-daily, orally-dosed tepotinib for treating certain adult patients with metastatic non-small...
Five major stakeholders praise PDUFA performance to date and suggest improvements to be included in the 2022 PDUFA 7 reauthorization.
Former FDA commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein say the Trump administration and FDA cant afford to repea...
Ipsen says it is planning to submit an NDA for palovarotene and its use in treating patients with fibrodysplasia ossificans progressiva.