FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Removes Clozapine REMS Program

[ Price : $8.95]

FDA removes a required risk evaluation and mitigation strategies program for clozapine and its requirement to report results of ab...

4 Observations on AstraZeneca FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 issued following an inspection at the AstraZeneca Frederick, MD, drug manufacturing facility.

Emalex Ecopipam Meets Tourette Study Endpoints

[ Price : $8.95]

Emalex Biosciences says it will meet with FDA to discuss submitting an NDA for its ecopipam to treat Tourette syndrome following s...

Tandem Diabetes Insulin Algorithm Cleared for Type 2

[ Price : $8.95]

FDA clears Tandem Diabetes Cares next-generation automated insulin delivery algorithm, Control-IQ+ technology, for use in people w...

Contaminated SinuCleanse Nasal Wash Recalled

[ Price : $8.95]

Ascent Consumer Products recalls one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System following a confirmed test r...

Entrada Clinical Hold Lifted on Duchenne Drug

[ Price : $8.95]

FDA lifts a 12/2022-ordered clinical hold on Entrada Therapeutics Duchenne muscular dystrophy therapy ENTR-601-44 and provided aut...

Ex-CDER Head Cavazzoni Rejoins Pfizer

[ Price : $8.95]

Former CDER director Patrizia Cavazzoni rejoins Pfizer as the companys chief medical officer.

Medtronics Brain Stimulator for Parkinsons Approved

[ Price : $8.95]

FDA approves a Medtronic PMA for its BrainSense Adaptive deep brain stimulation and BrainSense Electrode Identifier for use in Par...

FDA Trying to Rehire 300 Staff Recently Fired

[ Price : $8.95]

FDA moves over the weekend to rehire up to 300 scientists and reviewers who were terminated last week as part of the Trump Adminis...

No Panel Meeting for Brensocatib NDA

[ Price : $8.95]

FDA tells Insmed that it does not currently plan to hold an advisory committee meeting to discuss the companys NDA for brensocatib...