News

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 ...
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 ...
FDA's Makary sought to reject KalVista’s drug: report
FDA Commissioner Marty Makary reportedly initiated a brief request last week to decline approval of a rare disease drug ...
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, ...
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 ...
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Acting head of FDA drug evaluation center to retire
Curay, MD, acting director of the FDA’s Center for Drug Evaluation and Research, will step down in July after more than eight years at the agency, Bloomberg Law reported June 23. In an internal email ...
STAT5h
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 ...
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 ...
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 ...
KSL23h
FDA approves HIV drug based on University of Utah biochemist's findings
Utah biochemist Wesley Sundquist has achieved yet another milestone with the Food and Drug Administration approval of an ...
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 ...