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Precigen BLA for Respiratory Papillomatosis Therapy

[ Price : $8.95]

FDA accepts for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy f...

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...

BMS Files sBLA for Opdivo+Yervoy in Colon Cancer

[ Price : $8.95]

FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) plus Yervoy (ipilimumab) for a firs...

Compounders Sue FDA Over Semaglutide Shortages

[ Price : $8.95]

Drug compounding operations sue FDA in northern Texas federal court, seeking an order to reverse the agency decision last week to ...

Invivyd EUA Request to Expand Covid Therapy Denied

[ Price : $8.95]

FDA rejects an Invivyd request to expand the existing emergency use authorization for pre-exposure prophylaxis of Covid-19 EUA for...

Wegovy, Ozempic Shortages Resolved: FDA

[ Price : $8.95]

FDA says semaglutide injection product shortages (Novo Nordisks Wegovy and Ozempic) are resolved.