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Drug Approvals

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Latest From Approvals

Daiichi Sankyo Plays Long Game With Quizartinib Outside Japan

Japanese company Daiichi Sankyo has its eye on first-line FLT3-ITD AML indication after rejection of relapsed/refractory plans in EU and US.

Europe Drug Review

ANDA Approval Records Will End As US FDA Mops Up Backlog

CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.

Generic Drugs Review Pathway

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Merck Sharp & Dohme's Ebola vaccine, Ervebo. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

Approvals Europe

Keeping Track: Oxbryta Approval Headlines Pre-Thanksgiving Week Of News

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

US FDA Performance Tracker Approvals

Hello NMPA: China Approval For Astellas's Xtandi, Keytruda Set For Fourth Indication

Astellas’s Xtandi gets its latest approval in China, where Merck’s Keytruda is set for another win.

China Regulation

EMA Heeds Ombudsman’s Advice On Avoiding Perception Of Bias In Drug Evaluations

An inquiry by the EU Ombudsman has prompted the European Medicines Agency to introduce changes to ensure that its experts, who advise companies in the premarket phase, are not appointed to evaluate marketing applications for the same drugs.

Approvals Research & Development
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