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FDA issues response to Dynavax's HEPLISAV-B sBLA By Investing.com
Investing.com· 16 hours agoDynavax (NASDAQ:DVAX) Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and...
What Medicare beneficiaries need to know about generic medications
Fortune via AOL· 8 hours agoWhat can make similar generics different Her experience raises the question: How can two generics...
Qiagen’s QIAstat-Dx respiratory diagnostic wins FDA clearance
Medical Device Network via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has cleared Qiagen’s QIAstat-Dx Respiratory Panel Plus...
UPDATE 1-US FDA declines to approve expanded use of Dynavax's hepatitis B vaccine
Reuters via Yahoo Finance· 21 hours agoDynavax Technologies said on Tuesday the U.S. Food and Drug Administration (FDA) has declined to approve the expanded ...
Moderna Tumbles After The FDA Throws A Curveball On Its Second Product
Investor's Business Daily· 5 days agoModerna stock toppled Friday after the Food and Drug Administration delayed an approval decision on...
FDA warns some packaged baby food contains potentially toxic metals
WFTV via Yahoo News· 20 hours agoParents with newborn babies may want to listen to this new warning from the U.S. Food and Drug ...
Discretion No More: FDA’s New Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 1 day agoOn April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations to make explicit ...
FDA issues recall statement on insulin pump app after glitch causes more than 200 injuries
USA TODAY via Yahoo News· 5 days agoThe U.S. Food and Drug Administration has issued a recall correction for an app that connects with an insulin pump ...
US FDA declines expanded use of Dynavax's hepatitis B vaccine on insufficient data
Reuters via Yahoo News· 21 hours agoThe Food and Drug Administration in its so-called "complete response letter" stated that the data it...
Dupixent set for FDA review in adolescent chronic inflammatory sinus disease
Pharmaceutical Technology via Yahoo Finance· 2 days agoRegeneron and Sanofi could soon be adding another indication to its blockbuster immunology drug...