FDA clears a Cochlear Ltd. 510(k) for its new Cochlear Baha 6 Max Sound Processor for improving hearing outcomes for people with single-sided deafness...
FDA grants Kite accelerated approval for Yescarta (axicabtagene ciloleucel) for treating adult patients with relapsed or refractory follicular lymphom...
FDA tells Soleno Therapeutics that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR (diazoxide choline)...
FDA grants Viatria and Kindeva Drug Delivery tentative approval for budesonide/formoterol fumarate dihydrate, the first generic version of AstraZeneca...
Federal Register notice: CDER announces that beginning 3/15 it will support version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC)S...
Federal Register notice: FDA seeks comments on an information collection entitled Generic Clearance for the Collection of Quantitative Data on Tobacco...
Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency that the drug products are no l...
Federal Register notice: FDA sends to OMB an information collection entitled Study of Multiple Indications in Direct- to-Consumer Television Advertise...