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Product Reviews & Approvals

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Approvals

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Latest From Approvals

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

European Performance Tracker Drug Review

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
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Drug Reviews

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Latest From Drug Review

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

European Performance Tracker Drug Review

Celgene, Agios Drug Enasidenib Among New Filings At EMA

Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.

Drug Review Review Pathway

GSK's Tafenoquine Faces Questions Over Review Pathways At US FDA Panel

Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.

Advisory Committees Drug Review

Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi

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

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

GSK Moves Closer To Priority Review Voucher As US Panel Backs Malaria Drug Tafenoquine

GlaxoSmithKline's user fee date is July 22, four days before advisory committee review of 60 Degrees’ separate application for the compound.


Advisory Committees Drug Review
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