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US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies
The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a ...
FDA requires updated warning about rare heart risk with COVID shots
U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...
Cookie Recall Update as FDA Warning Issued to Customers in 15 States
The recall will remain active until the FDA and Carley's Inc. have resolved the labeling issue and ensured that all ...
US FDA Eliminates Risk Evaluation and Mitigation Strategies for CAR-T Cancer Therapies
(Reuters) -The U.S. Food and Drug Administration said on Friday that it had eliminated the risk evaluation and mitigation ...
Bay Area family shares frustrations after FDA rejects drug for ultra-rare Barth Syndrome
With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is ...
FDA expanding COVID vaccine warnings over rare heart side effect
The U.S. Food and Drug Administration is now requiring two common COVID-19 vaccines to update their warning labels to include ...
Seven Things to Know About ProPublica’s Investigation of the FDA’s Secret Gamble on Generic Drugs
ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These ...
FDA investigates patient deaths after treatment with Sarepta's gene therapy
The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver ...
iTolerance, Inc. Appoints Former FDA Senior Executive Wayne Pines to the Board of Directors
MIAMI, FL / ACCESS Newswire / June 25, 2025 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage privately-held ...
COVID vaccines heart risk warning update issued by FDA
"The committee has been plagued with persistent conflicts of interest and has become little more than a rubber stamp for any ...
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FDA accepts new drug application for sublingual epinephrine film
Anaphylm’s time to maximum epinephrine concentration is faster than other delivery vehicles. Perspective from Lynda Mitchell, MA, CAE The FDA has accepted Aquestive Therapeutics’ new drug application ...
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Spectral AI Announces Submission to FDA of its DeepView® System
DALLAS, June 30, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from ...