News

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 ...
Capricor says US FDA may not convene expert panel for co's cell therapy
Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration has indicated that an advisory panel review may ...
Drug official’s retirement sparks worry at FDA
Curay, the acting director of the FDA’s Center for Drug Evaluation and Research, internally announced her retirement Monday.
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 ...
Device that uses biodegradable polymers to repair peripheral nerves gets FDA clearance
A sutureless device for peripheral nerve repair by medical technology company Tissium, which has its US office in Cambridge, ...
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Top FDA drug regulator tells staff much is still in flux, as she prepares to retire
Curay, the top FDA drug regulator, acknowledged that much is still in flux at the agency and introduced a new deputy.
Supreme Court widens court options for vaping companies pushing back against FDA rules
The Supreme Court is siding with e-cigarette companies in a ruling that'll make it easier to sue over Food and Drug ...
FDA Recalls Chocolate Candies Over Milk Allergy Risk
People who are allergic to milk could have serious or life-threatening reactions if they eat the recalled chocolate, health ...
STAT9h
Radical transparency at the FDA, and a pivotal moment for vaccines
This is the web edition of D.C. Diagnosis, STAT's twice-weekly newsletter about the politics and policy of health and ...
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FDA Conditional Pathway Not Necessary, Rare Disease Experts Say, While Applauding Intent
Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...
FDA’s Drug Chief Latest to Depart During ‘Challenging Times’
Curay, the FDA’s acting top drug regulator, is stepping down from her post after serving at the agency for more than eight ...
Ginger Beer Recall Update as FDA Issues Highest Risk Warning
Rachel's Ginger Beer issued a voluntary recall for its "Cucumber x Tarragon Ginger Beer" in November last year due to ...