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US FDA approves expanded use of Bristol Myers' cancer cell therapy
Reuters via Yahoo News· 11 hours agoThe Food and Drug Administration's decision marks the fourth approval for Breyanzi, which can now be...
FDA Approves First Self-Test Collection Kit for HPV
WFMZ Eastern Pennsylvania and Western New Jersey· 17 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...
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 said it "never" inspected dental lab that made controversial AGGA device
CBS News· 3 days agoThe FDA never inspected Johns Dental Laboratories during more than a decade in which it made the...
Donation from Saratoga man leads to FDA approved cancer treatment
FOX 23 News Albany· 15 hours agoFDA approves new life-saving treatment for advanced melanoma.
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.
US FDA approves expanded use of Bristol's cancer cell therapy
Reuters via Yahoo Finance· 11 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 ...
Moderna Stock Seesaws After The FDA Throws It A Curveball
Investor's Business Daily· 6 days agoThe FDA was due to make a decision by May 12. Moderna emphasized the FDA has not said it found any...
Abeona Therapeutics bolsters finances as it seeks FDA approval for a key treatment
Crain's Cleveland Business· 18 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 ...
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MedTech Dive via Yahoo Finance· 6 days agoNearly three years after publishing draft guidance, the FDA has changed the title and added a...