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Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag
Zacks via Yahoo Finance· 6 days agoThe FDA grants priority review to Roche's (RHHBY) NDA for the inavolisib combination regimen for...
BrainsWay Receives Expanded FDA Labeling to Treat Late Life Depression - BrainsWay (NASDAQ:BWAY)
Benzinga· 19 hours ago...NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that the US Food and Drug Administration (FDA) has granted an expanded indication for the Company's Deep Transcranial Magnetic...
FDA Extends Review Deadline For Regeneron/Sanofi's Dupixent For 'Smoker's Lungs' Disease
Benzinga via Yahoo Finance· 4 days agoOn Friday, the FDA extended the target action date of priority review of supplemental application...
FDA approves Moderna's RSV shot for older adults
Becker’s Hospital Review· 23 hours agoThe FDA has given the green light to Moderna's mRNA-based respiratory syncytial virus vaccine, specifically for older adults, the drugmaker announced May 31. "This approval ...
FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men | Texarkana...
Texarkana Gazette· 2 days agoAdvocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular,...
FibroGen To Begin Trials on Tumor Treatment After FDA OK
Morningstar· 10 hours agoFibroGen can begin conducting clinical trials for its potential solid tumor treatment after regulators approved the company's application. The San Francisco-based company said Monday that the ...
FDA’s call for innovation: AI-driven solutions for Parkinson’s freezing of gait detection and...
Medical Device Network via Yahoo Finance· 7 days agoAs digital health technologies proliferate, the US Food and Drug Administration (FDA) is taking a...
FDA warns parents to avoid infant formula distributed by Texas company due to contamination
Associated Press· 3 days agoThe same bacteria sparked recalls and shortages of infant formula in 2022 after it was detected at a...
FDA responds to senator’s letter that calls out ‘FDA’s failure to act’ on NOW’s test results
Nutraingredients.com· 4 days agoLast April, South Carolina Congressman Jeff Duncan wrote to FDA Commissioner Dr. Robert Califf,...
FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men
Medical Xpress· 6 days agoAdvocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular,...
