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After FDA warning, Getinge trims sales of heart devices
Becker’s Hospital Review· 1 day 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 approves HPV self-test kit
United Press International via Yahoo News· 20 hours agoThe U.S. Food and Drug Administration has approved a kit that will allow women to collect their own vaginal sample for HPV screening, a move that could...
Abeona Therapeutics bolsters finances as it seeks FDA approval for a key treatment
Crain's Cleveland Business· 21 hours agoIn the April correspondence—known formally as a Complete Response Letter, or CRL—from the FDA, the regulatory agency said it needed additional information from Abeona on manufacturing ...
New Clozapine Data Suggest FDA Should Ease Restrictions
Medscape· 1 day agoThe risk for severe neutropenia with clozapine is minimal, suggesting that burdensome FDA-required hematologic monitoring should be relaxed, researchers said.
Delta-8 THC is legal in Oklahoma. But is it safe? FDA gives warning
Gannett via AOL· 20 hours agoAs the sales for delta-8 products have gone up, so have calls to Poison Control. Despite warnings...
FDA extends review of Ascendis Pharma's hypoparathyroidism drug By Investing.com
Investing.com· 2 days agoAscendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company, has received notice from the U.S....
Eisai initiates rolling Biologics License Application to US FDA for Leqembi® (lecanemab-irmb) for...
WROC Rochester· 1 day agoFood and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous...
US FDA approves expanded use of Bristol's cancer cell therapy
Reuters via Yahoo Finance· 15 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 ...
The Forces Weighing Against FDA Bans on Toxic Ingredients
Bloomberg· 1 day agoGood morning, it’s Fiona in New York. The FDA has missed a deadline for a proposed ban on a...
11 Stomach-Turning Non-Food Items The FDA Allows In Our Food
Mashed via Yahoo News· 3 days agoThe FDA allows for some surprising non-food items to get into the food supply. Here are some of the...
