FDA Related News

Drug Marketing Violation Letters Separated: FDA

CDERs Office of Prescription Drug Promotion no longer maintains an aggregated Web page of recent Warning Letters and Untitled Letters issued to drug m...

Human Drugs

Genentech Withdraws Tecentriq for Urothelial Carcinoma

Genentech says it is withdrawing the U.S. accelerated-approved indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial...

Medical Devices

Cochlear Baha 6 Sound Processor Cleared

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...

Biologics

Yescarta Accelerated Approval for Follicular Lymphoma

FDA grants Kite accelerated approval for Yescarta (axicabtagene ciloleucel) for treating adult patients with relapsed or refractory follicular lymphom...

Human Drugs

FDA Wants More Data on Prader-Willi Drug

FDA tells Soleno Therapeutics that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR (diazoxide choline)...

Human Drugs

Generic Symbicort Wins FDA Tentative Approval

FDA grants Viatria and Kindeva Drug Delivery tentative approval for budesonide/formoterol fumarate dihydrate, the first generic version of AstraZeneca...

Federal Register

CDER Announces Dates for eSubmissions

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

Info Collection on Tobacco Communications Data

Federal Register notice: FDA seeks comments on an information collection entitled Generic Clearance for the Collection of Quantitative Data on Tobacco...

Federal Register

7 No-Longer-Marketed ANDAs Withdrawn

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

Info Collection on DTC Study on Indications

Federal Register notice: FDA sends to OMB an information collection entitled Study of Multiple Indications in Direct- to-Consumer Television Advertise...