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FDA approves Moderna’s mRNA RSV vaccine
The Hill via Yahoo News· 10 hours 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...
Moderna Scores FDA Approval For Its Second Product - Respiratory Syncytial Virus Vaccine
Benzinga via Yahoo Finance· 6 hours agoOn Friday, the FDA approved Moderna Inc’s (NASDAQ:MRNA) mRESVIA (mRNA-1345), an mRNA respiratory...
FDA warns parents to avoid infant formula distributed by Texas company due to contamination
WSB Radio· 3 hours agoWASHINGTON — (AP) — U.S. health officials warned parents to avoid powdered infant formula sold by a...
FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company
The National Law Review· 3 hours agoOn May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug...
FDA Extends Review Deadline For Regeneron/Sanofi's Dupixent For 'Smoker's Lungs' Disease
Benzinga via Yahoo Finance· 10 hours agoOn Friday, the FDA extended the target action date of priority review of supplemental application...
Avita obtains FDA approval for cell harvesting device Recell GO System
Medical Device Network via Yahoo Finance· 15 hours agoThese advancements simplify the user interface, allowing medical teams to deliver consistent,...
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
Associated Press· 11 hours agoapproval as a medication. In their assessment, FDA scientists said that patients who received MDMA...
FDA’s review of MDMA for PTSD highlights study bias and safety concerns
Ars Technica· 2 hours agoThe agency noted significant flaws in the design of the underlying clinical trials as well as safety...
Moderna secures a second FDA vaccine approval as Spikevax sales plummet
Fast Company Magazine· 5 hours agoThe vaccine will be Moderna’s second product to enter the U.S. market after the FDA’s approval of...
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks via Yahoo Finance· 12 hours agoPer the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication...