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Articles tagged with "Food and Drug Administration"

FDA Approves Valeant’s Drug to Treat Plaque Psoriasis

Reuters Staff  |  

(Reuters)—The U.S. Food and Drug Administration has approved Valeant Pharmaceuticals International Inc.’s brodalumab (Siliq) to treat adults with moderate to severe plaque psoriasis. Brodalumab is administered as an injection. Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond, or have stopped responding to other systemic therapies,…

Biosimilar Update: ACR Says FDA Draft Guidance Is Promising & Biosimilar to Humira (Adalimumab) Enters Regulatory Review

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The ACR has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development. Also, BI 695501, a biosimilar to Humira (adalimumab) made by Boehringer Ingelheim, has been accepted for regulatory review in both the U.S. and Europe. ACR Responds to FDA Biosimilar…

FDA Update: FDA Delays Baricitinib Review & Removes Bupropion & Varenicline Warnings

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FDA Review of Baricitinib Delayed The U.S. Food and Drug Administration (FDA) has extended the review period for baricitinib, an investigational medication for treating moderate to severe rheumatoid arthritis (RA).1 Baricitinib is a once-daily oral Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The New Drug Application (NDA) for baricitinib…

Trump Considering Dr. Scott Gottlieb to Head U.S. FDA

Toni Clarke  |  

(Reuters)—Dr. Scott Gottlieb, a partner at one of the world’s largest venture capital funds and a former deputy commissioner at the U.S. Food and Drug Administration, is being considered by President-Elect Donald Trump to run the agency, according to sources close to the transition team. Gottlieb, 44, a venture partner at New Enterprise Associates and…