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Latest From Approvals
Genentech’s ocrelizumab, a CD20-directed antibody, becomes first US-approved treatment for primary progressive multiple sclerosis and is also indicated for relapsing disease. Labeling includes warnings about infusion reactions, infections and malignancy but lacks a boxed warning or REMS.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for centralized EU marketing authorization. Here’s a summary of their March 2017 recommendations.
Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.
The latest drug development news and highlights from our US FDA Performance Tracker.
Original new drugs and biologics recently approved by US FDA.
After overcoming regulatory hurdles, Newron may have tough time competing in US against market stalwart Azilect; eight Parkinson's drugs are in Phase III trials.
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