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Drug Approvals

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New EU Approvals

A listing of EU centralized approvals of new active substances, including brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).

European Performance Tracker Approvals

Janssen’s Apalutamide First To Gain Approval Under International Work Sharing Program

The ACSS Consortium’s work-sharing pilot for new drugs has yielded its first twin approval, for Janssen’s prostate cancer treatment, apalutamide.
Approvals Regulation

Patient-Reported Outcome Data Helps Dermira’s Hyperhidrosis Drug Qbrexza Win US FDA Nod

Co-primary endpoint was Axillary Sweating Daily Diary, a novel PRO instrument developed by Dermira with FDA input, assessed sweating severity and impact of sweating on a person’s daily activities; results complemented quantitative measure of sweat production in Phase III trials.


Approvals Regulation

US FDA Likely To Shatter Novel Approval Record In 2018

With at least 40 pending novel products, FDA seems poised to break its 2017 approval record of 46, and could even reach 60.

Approvals Drug Review

Latest Japan Approvals Include Entyvio, Imfinzi, World-First Indication

Takeda’s global blockbuster GI drug Entyvio has been approved in Japan, although its local sales prospects appear limited, while two novel cancer drugs from AstraZeneca and a world-first indication have also been cleared by the health ministry.

Japan Approvals

European CHMP Opinions And MAA Updates

This is a monthly update listing 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.

Approvals Drug Review
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