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The European Commission has approved Eli Lilly’s self-injectable diabetes drug Trulicity, a move that follows the FDA’s approval in September. Read More
The European Medicines Agency has approved an intramuscular long-acting form of Novartis’ Signifor for adults with the rare hormonal disorder acromegaly, which has not been controlled by surgery or older somatostatin analogue (SSA) therapies. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
Citing quality problems at two of Ranbaxy’s Indian manufacturing facilities, the FDA has revoked its tentative approvals for two of the company’s ANDAs, one for a generic of AstraZeneca blockbuster Nexium and the other for Hoffman-LaRoche AIDS drug Valycte. Read More
An advisory panel of the European Medicines Agency last week recommended approval of two AbbVie drugs for hepatitis C, a Genzyme drug for type 1 Gaucher disease, and a change in classification of HRA Pharma’s emergency contraceptive. Read More
The FDA touted its approval of an abuse-deterrent, single-entity opioid yesterday and sought to beat back congressional criticism it has done little to curb prescription drug abuse. Read More
UK’s healthcare cost watchdog says Novartis must provide significantly more clinical trial data on its hives drug Xolair before the group can recommend the therapy for national coverage. Read More
The FDA’s citizen petition process is overloaded with meritless petitions whose only purpose is to try to delay competition from generic drugs, despite past efforts at reforming it, the agency says. Read More