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Moderna (MRNA) Falls as FDA Extends Review Time for RSV Vaccine
Zacks· 21 hours agoFree Report) were down 4.4% on May 10 after the company announced that the FDA has delayed the review timeline for its mRNA-based, respiratory syncytial virus (RSV) vaccine ...
FDA says hundreds injured due to software glitch connecting insulin pumps to iPhones
WFTV via Yahoo News· 1 day agoEarlier this year, there was a glitch in the software that connects the “t:slim X2″ insulin pump to...
FDA Issues Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
The National Law Review· 3 days agoOn May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule...
Sanofi (SNY), Regeneron's Dupixent sBLA Gets FDA Priority Tag
Zacks· 21 hours agoFree Report) and partner Regeneron (REGN Quick QuoteREGN - Free Report) announced that the FDA has accepted their supplemental biologics license application (sBLA) seeking ...
FDA Could Update Blood Donation Guidelines to Avoi | Newswise
Newswise· 21 hours agoJose Lucar is an associate professor of infectious diseases at the GW School of Medicine and Health Sciences. Maria Elena Ruiz is an associate professor o
4 Your Health: FDA-approved drug aims to help menopausal women with hot flashes, night sweats
WTAE Pittsburgh· 3 hours agoMost women know menopause can come with hot flashes and night sweats that can impact sleep and be...
Merus Carcinoma Treatment Awarded US FDA's Breakthrough Therapy Designation
Market Watch· 13 hours agoThe breakthrough therapy designation is designed by the FDA to expedite the development and evaluation of treatments for serious or life-threatening conditions if they have ...
FDA To Hold Advisory Committee Meeting On MDMA Therapy For PTSD, Welcomes Public Comment
Forbes· 3 days agoThe U.S. Food and Drug Administration (FDA) recently announced an upcoming committee meeting...
FTC Challenges More Patent Listings in the FDA’s Orange Book | JD Supra
JD Supra· 19 hours agoThe FTC recently announced that it has sent another round of letters disputing additional patent listings in the FDA’s Orange Book. With this latest action, the FTC has now ...
FDA begins renewal review for Marlboro HeatSticks devices
Winston-Salem Journal· 4 days agoThe FDA began Friday its scientific review for the IQOS 2.4 and 3.0 systems holders and chargers and...