Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Product Reviews & Approvals

Set Alert for Product Reviews and Approvals

Approvals

Set Alert for Approvals

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
See All

Drug Reviews

Set Alert for Drug Reviews

Latest From Drug Review

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

US FDA Office Of New Drugs Likely To Be Headed By Deputy Director Stein

Peter Stein is a familiar face within OND and has been working alongside CDER Director Janet Woodcock on the proposed “modernization” of OND. As a previous recruit from outside FDA, Stein has had time to make the key connections and adjustments to working inside government.
FDA Leadership

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

Pain Therapeutics Appeals Remoxy CRL In Likely Last Ditch Effort To Save Abuse-Deterrent Opioid

Meeting with US FDA in January will aim to reverse fourth rejection in 10 years; firm still criticizing agency even as it works to reconcile their positions.
Complete Response Letters Neurology

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

Keeping Track Of Breakthrough Therapy Designations: Depression, Headaches, Hepatitis

The latest developments in one of the US FDA's favorite pathways.

US FDA Performance Tracker Review Pathway
See All
UsernamePublicRestriction

Register