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Product Reviews & Approvals

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Approvals

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Latest From Approvals

EU Approval In Sight For New ATMP, Products For XLH And Diabetes, And 2nd Biosimilar Herceptin

A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a multiple myeloma product, and a sea squirt-based MS drug was withdrawn from the review process.

Europe Approvals

FDA's NDA And BLA Approvals: Xepi, Admelog, Ixifi

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

First Biosimilar Neulasta In Final Stages Of EMA Review Process

A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.

Biosimilars Advisory Committees

‘Outstanding Issues’ Clarified For Nine Products Nearing EU Review End – Including Neulasta Biosimilar

Ammtek, Pfizer, Portola and Roche are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are nearing the end of the review pathway. Questions are also in store for the sponsor of a biosimilar version of filgrastim.

Europe Approvals

Lilly, Novartis, Jazz and Ionis Take New Products To EMA

Lilly’s migraine prevention therapy, galcanezumab, is among the nine new products that companies have submitted to the European Medicines Agency for evaluation in recent weeks.

Europe Approvals

Orphans Dominate Products Seeking End-Of-Year Joy From CHMP

Five of the nine products that could this week be recommended for EU approval have orphan designation. The final meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London.

Drug Review Approvals
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Drug Reviews

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Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

First Biosimilar Neulasta In Final Stages Of EMA Review Process

A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.

Biosimilars Advisory Committees

Lilly, Novartis, Jazz and Ionis Take New Products To EMA

Lilly’s migraine prevention therapy, galcanezumab, is among the nine new products that companies have submitted to the European Medicines Agency for evaluation in recent weeks.

Europe Approvals

Orphans Dominate Products Seeking End-Of-Year Joy From CHMP

Five of the nine products that could this week be recommended for EU approval have orphan designation. The final meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London.

Drug Review Approvals

Complete Response Letters: Firms See Value In Public Release, Don't Expect It Will Happen

One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.

Complete Response Letters Drug Review

US FDA Readies For Assessment Of IND Communications With Sponsors

Third-party contractor will conduct evaluation of agency's communications with sponsors throughout IND process as part of PDUFA VI commitments.

Drug Review FDA
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