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Product Reviews & Approvals

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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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Drug Reviews

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Latest From Drug Review

EMA Prepares Approval Verdict On Beovu, Idhifa, Recarbrio

Products from Novartis, Celgene and Merck could get an EU approval recommendation at this week's CHMP meeting.

Drug Review Europe

Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs

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

US FDA Performance Tracker Cancer

Brinavess Rejected By Advisory Cmte., Leaving US FDA To Mull Lifting Clinical Hold On Correvio's AFib Drug

Cardiovascular and Renal Drugs Advisory Committee voted 11-2 against approval for Correvio's atrial fibrillation drug Brinavess over cardiovascular safety concerns; the agency would have to lift the long-standing  clinical hold on the drug before the company can do any further study in humans.
Advisory Committees Cardiovascular

US FDA Pushes Back Against Critics: Breakthrough Is Not A Drug 'Beauty Contest'

Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.

Drug Review FDA

US FDA's Office Of New Drug Leaders Listen To Stakeholders

Twenty-five officials of FDA's Office of New Drugs gather to hear recommendations from stakeholders on what they can do to improve drug development programs.
FDA Drug Review

Biosimilar Sponsors Want Off-The-Record Labeling Discussions With US FDA

Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions written record; negotiations for BsUFA III may be opportunity to create such a process.

Biosimilars Intellectual Property
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