Pink Sheet is part of the Business Intelligence Division 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

Keeping Track: Zelboraf Takes Breakthrough Path For Rare Blood Disease; Teva Resubmits Generic EpiPen

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

Performance Tracker Approvals

FDA's NDA And BLA Approvals: Qvar, Carospir, Nikita

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews

The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.

Drug Review Profile Review Pathway

FDA's Generic Approvals Catch A Bit Of Breath In July But Continue At Fast Pace

US Generic drug approvals drop in July, but still are above the monthly average for the year, potentially signaling a new expected output.

FDA Generic Drugs

Keeping Track: US FDA Approvals Of Mavyret, Idhifa, Vyxeos Headline Week Of Breakthroughs, Hematology And Hematology BTDs

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

Approvals Biosimilars

Don't Lose Track: Review And Approval News On Opdivo, Kalydeco And More

US FDA had a busy week. Here's some bullet points of product development events you may have missed.

Approvals Drug Review
See All

Drug Reviews

Set Alert for Drug Reviews

Latest From Drug Review

Breakthrough Requests Keep Climbing

Sponsors are seeking US “Breakthrough Therapy” Designations at a record pace in FY 2017.

Drug Review Regulation

Kite’s Axi-Cel CAR-T: No Adcomm, No Problem

Next CAR-T in line at US FDA, Kite’s axicabtagene ciloleucel, looks headed toward an early approval with the agency confirming no panel will be scheduled, according to the firm. But the company and FDA may have benefited from an advisory committee review.

Advisory Committees 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

Drug Review Profiles: Behind The Scenes At US FDA

A year in our long-running series of deep dives into FDA review documents.

Drug Review Profile Review Pathway

US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews

The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.

Drug Review Profile Review Pathway

US FDA Panel Weighs Design Of A Pre-approval Safety Study For Janssen's Sirukumab

IL-6 inhibitor should be compared to another biologic to exclude a multi-fold increase in the risk of death, advisers say; FDA assures the panel's industry representative it is not considering an across-the-board requirement for large safety studies of rheumatoid arthritis treatments.

Advisory Committees Biologics
See All
UsernamePublicRestriction

Register