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Drug Approvals

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Latest From Approvals

Potential Cardiovascular Blockbuster Inclisiran Among New Filings At EMA

The European Medicines Agency has agreed to review pan-EU marketing applications for a number of new medicines.

Europe Approvals

FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims

Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).

FDA Legal Issues

FDA Requests Belviq Be Pulled From The US Market Due To Cancer Risk

The agency requested the weight loss pill be voluntarily recalled by Eisai, the death knell for a trio of obesity drugs that launched early in the last decade. 
Metabolic Disorders Drug Safety

EU Speedy Review Success For Kite But Not For Lilly

KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib

Drug Review Europe

Keeping Track: Seqirus Pandemic Flu Vaccine Approved; Trevena Resubmits Oliceridine

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

US FDA Performance Tracker Drug Review

EU Regulatory System Attacked Over Quality Of Approvals

If anyone can throw cold water on the claimed benefits of some of Europe's most recently approved medicines, it’s the international drug bulletin, Prescrire. In an assessment of 108 of the pharma industry’s latest offerings, it gives a cautious welcome to some but says that more than half bring nothing new and others could even be dangerous to patients.

Europe Drug Approval Standards
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