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Drug Approvals

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Latest From Approvals

Keeping Track Of Immuno-Oncology: An Updated Guide To Applications At FDA

Infographic highlights products in the burgeoning PD-1/L1 checkpoint inhibitor class either approved or under review, from the Pink Sheet's FDA Performance Tracker. 
 
Cancer Approvals

European CHMP Opinions And MAA Updates

This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

Keeping Track Of Approvals: Cancer, Cancer, And A Two-Week Cancer Review

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

Four Drugs Set For EU Approval, EMA Holds Fire On Pacritinib

The European Medicines Agency this week recommended marketing approval for four medicines, including a drug for use in countries outside the EU.

Europe Approvals

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.
Drug Review Europe

Novartis And Stemline Try For Fast-Track EU Review

The European Medicines Agency is this week deciding whether it will fast track its review of orphan drugs that Novartis is developing for the treatment of Cushing's syndrome and Stemline Therapeutics is developing for the hematologic malignancy, BPDCN.
Drug Review Regulation
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