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EMA
Latest Headlines
Latest Headlines
Genzyme's $150M plant upgrade starts to pay off
The company says in a release that the FDA and the EMA have given approval to a filling and finishing operation for Myozyme and Lumizyme, treatments for the enzyme deficiency known as Pompe disease.
SkyePharma's inhaler takes step toward EMA approval
After years of delays and rejections, SkyePharma is finally getting some good news on Flutiform.
UPDATED: EMA approves Novartis' Gilenya
The drug dodged a bullet in the EU when the European Medicines Agency said it could remain on the market.
Novartis reports patient taking Gilenya developed rare brain disease
Expectations for the blockbuster status of Gilenya dimmed when Novartis disclosed that a patient taking the drug has developed a rare brain disease.
FDA builds program for outsourcing foreign plant inspections
The FDA likes the look of a program to outsource inspections, but it's caught in one of those pressure sandwiches between competing congressional concerns.
CHMP chair makes sudden exit from EMA
A top regulator suddenly bowed out at the European Medicines Agency, as his other employer--France's drug agency AFSSAPS--continues to draw fire.
UPDATED: EMA OKs Byetta for expanded treatment
The European Medicines Agency has approved an expanded use of Byetta for type 2 diabetes patients.
WHO joins agencies in beefing up inspections of API facilities
The World Health Organization ( WHO ) is joining an effort to extend the reach of regulatory inspections of API facilities and reduce duplication by sharing resources, InPharm reports. The effort was...
Europe issues 2nd recall of drugs made by Ben Venue
Ben Venue is back in the news for product quality shortcomings with Europe's recommendation Friday of additional precautionary drug recalls. The European Medicines Agency issued a similar recall for
Europe takes precautions with Ben Venue drugs
Ben Venue 's manufacturing QA troubles, which prompted the voluntary closing of its Bedford, OH plant, have rippled across the Atlantic. The European Medicines Agency issued a precautionary recall of
