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March 25, 2020

Compliance Policy Guide Section 110.800 Post Detention Sampling Guidance for Industry

Issued by: Guidance Issuing Office Office of the Associate Commissioner for Regulatory Affairs This guidance is for immediate implementation. FDA is issuing this guidance for immediate […]
March 25, 2020

FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data

For Immediate Release: January 29, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs – Food and Drug Administration Stephen M. Hahn M.D. […]
March 25, 2020

FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

For Immediate Release: January 09, 2020 Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be […]
March 25, 2020

FDA approves new treatment for adults with migraine

For Immediate Release: December 23, 2019 The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or […]
March 25, 2020

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

For Immediate Release: December 19, 2019 The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of […]
March 25, 2020

Trump Administration takes historic steps to lower U.S. prescription drug prices

For Immediate Release: December 18, 2019 Français Today, President Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug […]
March 25, 2020

FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

For Immediate Release: December 13, 2019 Español The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy […]
March 25, 2020

FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations

For Immediate Release: December 10, 2019 Español The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical […]
March 25, 2020

FDA approves first generics of Gilenya

For Immediate Release: December 05, 2019 The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment […]
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