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Drug Approvals

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Ocrevus Launching Quickly Even After Manufacturing Worries Delayed US Approval

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.

Approvals Biologics

CHMP’s March Recommendations Include Dinutuximab, Nonacog Beta Pegol And Trumenba

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.

Approvals Europe

User Fees: Should US FDA Incur Penalties For Missed Deadlines?

Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.

Approvals FDA

Keeping Track: US FDA Clears Three Novel Agents Over Three Days – Bavencio, Symproic And Xadago

The latest drug development news and highlights from our US FDA Performance Tracker.

Performance Tracker Approvals

FDA's NDA And BLA Approvals: Xadago, Bavencio, Symproic

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Newron's Parkinson's Drug Xadago Has Narrower Indication Than Teva's Azilect

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.

Approvals Regulation
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