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Genentech says it is withdrawing the U.S. accelerated-approved indication for Tecentriq (atezolizumab) in prior-platinum treated m...[ Price : $8.95]
FDA clears a Cochlear Ltd. 510(k) for its new Cochlear Baha 6 Max Sound Processor for improving hearing outcomes for people with s...[ Price : $8.95]
FDA grants Kite accelerated approval for Yescarta (axicabtagene ciloleucel) for treating adult patients with relapsed or refractor...[ Price : $8.95]
FDA tells Soleno Therapeutics that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR...[ Price : $8.95]
FDA grants Viatria and Kindeva Drug Delivery tentative approval for budesonide/formoterol fumarate dihydrate, the first generic ve...[ Price : $8.95]
Federal Register notice: CDER announces that beginning 3/15 it will support version 1.1 of the Clinical Data Interchange Standards...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection entitled Generic Clearance for the Collection of Quantita...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency that the dr...