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Product Reviews & Approvals

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Approvals

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Latest From Approvals

All Or Nothing: Paratek Withdraws EU Filing For Nuzyra

A month after being asked to attend an oral explanation meeting with the European Medicines Agency, Paratek Pharmaceuticals has decided to withdraw the EU marketing application for its broad spectrum antibiotic, Nuzyra. The company is one of two drug sponsors that has withdrawn an EU marketing application in October.

Europe Drug Review

Amarin Seeks EU Fast-Track For Potential Cardiovascular Blockbuster

Amarin’s cardiovascular risk reducing drug, Vascepa, is among four new products being considered for accelerated assessment by the European Medicines Agency.

Drug Review Europe

Daiichi Sankyo’s AML Drug Among Nine CHMP Hopefuls

Will regulators in the EU follow their US counterparts in requiring more efficacy data for Daiichi Sankyo’s acute myeloid leukemia drug quizartinib, which is already approved in Japan?

Drug Review Approvals

Keeping Track: Scenesse, Reyvow, and Beovu Make Trio Of Novel Approvals

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

US FDA Performance Tracker Approvals

Keeping Track: US FDA, Industry Roar Into Fourth Quarter With Bevy Of Regulatory Announcements

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

US FDA Performance Tracker Approvals

Gilead’s Descovy Nabs Limited HIV Prophylaxis Indication Pending A New Study In Women

US FDA approves a PrEP indication for emtricitabine/tenofovir alafenamide that excludes cisgender women due to a lack of efficacy evidence; Gilead will conduct a new randomized trial with a novel design in women comparing Descovy's efficacy and safety against external controls and Truvada.

Approvals Post Market Regulation & Studies
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Drug Reviews

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Latest From Drug Review

All Or Nothing: Paratek Withdraws EU Filing For Nuzyra

A month after being asked to attend an oral explanation meeting with the European Medicines Agency, Paratek Pharmaceuticals has decided to withdraw the EU marketing application for its broad spectrum antibiotic, Nuzyra. The company is one of two drug sponsors that has withdrawn an EU marketing application in October.

Europe Drug Review

Early GMP Compliance Seen As A Key To Avoiding Complete Responses

Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.

Manufacturing Quality

Cefiderocol Approval Likely After Panel Vote, But Future Still Clouded

Shionogi's cUTI drug clears US FDA advisory committee by 14-2, though a black box warning is possible after one of the clinical studies showed a potential mortality imbalance disfavoring cefiderocol in other diseases.

Advisory Committees Infectious Diseases

US FDA Generic Approvals Break 900 Barrier In FY 2019

The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.

Generic Drugs Review Pathway

Amarin Seeks EU Fast-Track For Potential Cardiovascular Blockbuster

Amarin’s cardiovascular risk reducing drug, Vascepa, is among four new products being considered for accelerated assessment by the European Medicines Agency.

Drug Review Europe

US FDA's GDUFA-Related FTEs Increase … Except In CBER

Employees performing generic drug user fee program and related work increased nearly 68% between FY 2014 and FY 2018; Costs, as well as dependence on fees to pay for them, also increased during the period.

Review Pathway Generic Drugs
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