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FDA: Cue Health COVID tests may return false positive, negative results, so throw them away
Naples Daily News via Yahoo News· 2 days agoCheck your cabinets. The U.S. Food and Drug Administration (FDA) warned consumers and healthcare...
US FDA approves expanded use of Bristol Myers' cancer cell therapy
Reuters via AOL· 8 hours agoThe Food and Drug Administration's decision marks the fourth approval for Breyanzi, which can now be...
After FDA warning, Getinge trims sales of heart devices
Becker’s Hospital Review· 22 hours agoAfter the FDA instructed healthcare facilities to avoid using two Getinge heart devices because of quality and safety concerns, the company stopped promoting the products.
FDA issues warning to Cue Health over COVID-19 test By Investing.com
Investing.com· 2 days agoCue Health Inc. (NASDAQ:HLTH), a healthcare technology company, has received a warning letter from...
US FDA approves expanded use of Bristol's cancer cell therapy
Reuters via Yahoo Finance· 8 hours agoMay 15 (Reuters) - The U.S. Food and Drug Administration on Wednesday approved the expanded use of Bristol Myers Squibb's cancer cell therapy Breyanzi to include the treatment of adults with ...
FDA issues response to Dynavax's HEPLISAV-B sBLA By Investing.com
Investing.com· 1 day agoDynavax (NASDAQ:DVAX) Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and...
New Clozapine Data Suggest FDA Should Ease Restrictions
Medscape· 24 hours agoThe risk for severe neutropenia with clozapine is minimal, suggesting that burdensome FDA-required hematologic monitoring should be relaxed, researchers said.
Earnings call: Liquidia Corporation eyes FDA nod for YUTREPIA By Investing.com
Investing.com· 1 day agoLiquidia Corporation (LQDA) reported its financial results for the first quarter of 2024 and...
The Forces Weighing Against FDA Bans on Toxic Ingredients
Bloomberg· 19 hours agoGood morning, it’s Fiona in New York. The FDA has missed a deadline for a proposed ban on a...
FDA posts final guidance on remanufacturing medical devices
MedTech Dive via Yahoo Finance· 6 days agoNearly three years after publishing draft guidance, the FDA has changed the title and added a...