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Dupixent set for FDA review in adolescent chronic inflammatory sinus disease
Pharmaceutical Technology via Yahoo Finance· 18 hours agoRegeneron and Sanofi could soon be adding another indication to its blockbuster immunology drug...
Qiagen’s QIAstat-Dx respiratory diagnostic wins FDA clearance
Medical Device Network via Yahoo Finance· 22 hours agoThe US Food and Drug Administration (FDA) has cleared Qiagen’s QIAstat-Dx Respiratory Panel Plus...
FDA Warns Against Use of Cue Health COVID-19 Tests
GenomeWeb News· 13 hours agoAccording to the agency's warning letter, the San Diego-based company implemented multiple changes to its COVID-19 tests without authorization from the FDA, including changes ...
EPA, USDA, and FDA to Clarify Overlapping Biotechnology Regulatory Frameworks
The National Law Review· 14 hours agoOn May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) released a joint plan to ...
As the FDA evaluates ecstasy treatment for PTSD, questions mount about the evidence
WAMC Northeast Public Radio· 20 hours agoAn approval by the agency would represent an enormous milestone for the movement to bring psychedelics into the mainstream of mental health care. An FDA rejection of MDMA, ...
Guardant Health preps for FDA advisory panel review of its blood-based colorectal cancer screening...
FierceBiotech· 15 hours agoGuardant Health has its sights set on redefining how people get checked for colorectal cancer, and...
FDA approves first medication to reduce allergic reactions to food
22 WSBT South Bend· 12 hours agoA new tool has been introduced to reduce allergic reactions. While there is no cure to food...
FDA Orders Recall on Diabetes App After Glitch Injures 224 Users
iTech Post· 1 day agoThe U.S. Food and Drug Administration (FDA) issued a Class I recall t:connect, an iOS app used to...
FDA issues 'most serious type of recall' for insulin pump-related iOS app
FOX Business· 2 days agoThe U.S. Food and Drug Administration has issued a Class I "most serious type of recall" for an iOS...
Moderna (MRNA) Falls as FDA Extends Review Time for RSV Vaccine
Zacks· 1 day 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 ...
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