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CBER's Regulatory Activity in 2018: A Reading List

The US FDA's biologics center invested heavily in preparation for coming waves of advanced therapies. 
Regulation Biologics

Scenes From A Shutdown: US FDA Hides It Well

FDA's two recent advisory committee meetings at its White Oak campus offer no obvious clues that agency is struggling due to dwindling carryover balances and furloughed employees.
FDA Leadership

Roche Calls For Harmonized Regulations As Subcutaneous Herceptin Declined Trial Waiver In India

Roche has sought a harmonized regulatory approach for approval of innovative medicines and formulations in India, after its request for a trial waiver for subcutaneous Herceptin was turned down by an expert panel.
India Policy

EU Accelerated Assessment Tracker: Nine Definites So Far From 24 Requests In 2018

In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.

Europe Review Pathway

Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application

Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.
Review Pathway Drug Review

Gene Therapies: Accelerated Approval Open For Some, But Not All, Neurodegenerative Disease Treatments

US FDA’s Gottlieb tells J.P. Morgan that curative gene therapies may be ripe for accelerated approval while those targeting symptoms may require more conventional development programs; forthcoming agency guidance will articulate this divide specific to neurodegenerative diseases, he says.

Regenerative Medicine Review Pathway

Orphan Drugs Compose Majority Of Novel US Approvals For First Time Ever In 2018

Orphan drugs and priority reviews achieved historic highs in CDER's 2018 novel approval class, but share of products with breakthrough therapies took a slide. 
Approvals Drug Review

Roche Secures EU Fast-Track Review For Anticancers

The European Medicines Agency has okayed applications from Roche for EU accelerated review of two oncology drugs in late-stage development at the company
Europe Cancer

Why Advicenne's Kidney Disease Drug Reverted To Standard EU Review

The CEO of French firm Advicenne explains why the company did not win an accelerated EU assessment for its kidney disease drug ADV7103, and why it may well try again in future with another indication – and perhaps with other new drugs too.
Europe Regulation
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