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Top FDA vaccine official rejected broad use of Covid-19 shots, documents show
The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...
FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...
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FDA Mandates ADHD Drug Labels To Warn Of Weight Loss Risk
The FDA now requires ADHD extended-release drug labels to warn of weight loss risks in children under 6, urging monitoring ...
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FDA approves first-ever drug for macrophage activation syndrome in Still’s disease
The FDA has approved Gamifant as the first-ever treatment for macrophage activation syndrome in Still’s disease for adults ...
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 ...
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Top drug regulator is retiring as FDA departures mount
WASHINGTON — Jacqueline Corrigan-Curay, the top drug regulator at the Food and Drug Administration, is retiring from the ...
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FDA accepts new drug application for sublingual epinephrine film
The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...
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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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.