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FDA grants orphan drug status to lenabasum for dermatomyositis

July 20, 2018
FDA News

FDA approves TPOXX to treat smallpox

July 13, 2018
The FDA has approved an oral formulation of TPOXX for the treatment of smallpox, citing concerns that the infectious disease, long considered eradicated since 1980…
FDA News

FDA withdraws biosimilar draft guidance following public comments

June 21, 2018
The FDA has withdrawn a draft guidance intended to provide advice for biosimilar sponsors regarding the determination of similarity between the biosimilar and its…
FDA News

FDA approves Rituxan for pemphigus vulgaris

June 8, 2018
The FDA has approved rituximab for the treatment of adult patients with moderate-to-severe pemphigus vulgaris, a rare autoimmune blistering disease that affects the skin…
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