Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Product Reviews & Approvals

Set Alert for Product Reviews and Approvals

Approvals

Set Alert for Approvals

Latest From Approvals

Chloroquine ‘Approval’ For COVID-19 And The US FDA’s New Reality

Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.

Coronavirus COVID-19 Leadership

US FDA Decides Against Zolgensma Data Integrity Penalties As Novartis Bureaucratizes AveXis

Company’s promise to be more forthright, along with quality culture and policy upgrades, may have helped sway agency.

Quality Enforcement

European CHMP Opinions and MAA Updates

This is an update of 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.

Drug Review Europe

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include two new products, including Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. 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).

Europe Approvals

Keeping Track: US FDA Okays BMS’ Zeposia In MS, Nixes Lilly/BI’s Empagliflozin For Type 1 Diabetes

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Zolgensma and Seven Other Products Get CHMP Thumbs Up

Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.

Europe Approvals
See All

Drug Reviews

Set Alert for Drug Reviews

Latest From Drug Review

Colorectal, Bladder Cancer Therapies Are Top Prospects For April US FDA Approvals

Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.

US FDA Performance Tracker Drug Approval Standards

US FDA User Fee Renewals Remain On Schedule Despite Coronavirus

Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.

User Fees Drug Review

US FDA Exploring Virtual Advisory Cmtes.; Might Sponsors Want To Wait For In-Person Meetings?

Likelihood of webcast-only advisory committee meetings may depend on the extent of the coronavirus outbreak, Office of New Drugs Director Peter Stein tells the Pink Sheet in an interview.

Coronavirus COVID-19 Advisory Committees

CDER’s Woodcock On COVID-19: Missed User Fees Unlikely, But Some Work Will Be ‘Set Aside’

In a podcast interview, Janet Woodcock talks about review deadlines, prioritizing pre-approval inspections, and how advisory committees could be held in an era of social distancing.

Coronavirus COVID-19 Leadership

Coronavirus Sponsors Should Get Responses To Regulatory Requests Within One Day, US FDA Says

As part of the new Coronavirus Treatment Acceleration Program, FDA staff also are being reassigned to handle investigational therapy requests faster.

Coronavirus COVID-19 Drug Review

Coronavirus Demanding Focus Of US FDA’s Antiviral, Other Divisions

Office of New Drugs Director Peter Stein said in an interview that a large amount of coronavirus-related work is arriving at the FDA, but so far staff are keeping up.

Coronavirus COVID-19 Drug Review
See All
UsernamePublicRestriction

Register