FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Genentech Withdraws Tecentriq for Urothelial Carcinoma

[ Price : $8.95]

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

Cochlear Baha 6 Sound Processor Cleared

[ 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...

Yescarta Accelerated Approval for Follicular Lymphoma

[ Price : $8.95]

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

FDA Wants More Data on Prader-Willi Drug

[ Price : $8.95]

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

Generic Symbicort Wins FDA Tentative Approval

[ Price : $8.95]

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

CDER Announces Dates for eSubmissions

[ Price : $8.95]

Federal Register notice: CDER announces that beginning 3/15 it will support version 1.1 of the Clinical Data Interchange Standards...

Info Collection on Tobacco Communications Data

[ Price : $8.95]

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

7 No-Longer-Marketed ANDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency that the dr...

Info Collection on DTC Study on Indications

[ Price : $8.95]

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

Safety Alert on Thermal Imaging Devices

[ Price : $8.95]

FDA issues a device safety alert on thermal imaging systems intended to measure human body temperature because improper use could ...