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RNT Health Insights’ gastric cancer detection tool receives FDA BDD
Medical Device Network via Yahoo Finance· 19 hours agoIndia-based clinical-stage medical diagnostics company RNT Health Insights has received breakthrough...
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
ABC7 News· 1 day agoThe Food and Drug Administration posted its initial review of the drug Friday, ahead of a meeting of...
BrainsWay Receives Expanded FDA Labeling to Treat Late Life Depression - BrainsWay (NASDAQ:BWAY)
Benzinga· 16 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...
FibroGen To Begin Trials on Tumor Treatment After FDA OK
Morningstar· 7 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 Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks via Yahoo Finance· 4 days agoPer the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication...
FDA approves Moderna’s mRNA RSV vaccine
The Hill via Yahoo News· 4 days agoThe Food and Drug Administration (FDA) has approved Moderna’s RSV mRNA vaccine for adults older than 60 years. The approval makes RSV the second disease...
FDA approves Moderna's RSV shot for older adults
Becker’s Hospital Review· 21 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 ...
Psychoactive drugs are having a moment. The FDA will soon weigh in
The State· 20 hours agoPsychoactive drugs are having a moment. Investors are piling into the nascent field, and a host of medications based on MDMA, LSD, psychedelic mushrooms, ketamine, the South American plant mixture ...
MDMA Therapy For PTSD Closer To Legality As Key FDA Approval Meeting Approaches, Sparking Hope And...
Benzinga· 11 hours agoOn Tuesday, the FDA's Psychopharmacologic Drugs Advisory Committee will meet to discuss the drug application submitted by Lykos, providing the first clear indication of the ...
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...