Tag:
CHMP
Latest Headlines
Latest Headlines
GSK's Nimenrix gets green light in Europe
GlaxoSmithKline's meningitis vaccine Nimenrix has been granted approval in Europe by the Committee for Medicinal Products for Human Use (CHMP).
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.
CHMP gives thumbs up to Roche melanoma drug
The EU's Committee for Medicinal Products for Human Use has recommended that Roche 's Zelboraf be granted full marketing authorization to treat adults with BRAF V600 mutation-positive unresectable or
EMA nod for key new drugs from GSK, Merck, BMS
Three drugs recently approved in the U.S. to great fanfare have now won recommendations for sale in Europe. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use gave
EMA poses new questions on Avandia
European regulators are gathering more info about Avandia safety. The European Medicines Agency convened an unexpected meeting of its advisory committee yesterday to discuss the diabetes drug, and
EU advice on Avandia put off until September
The FDA needs some time to think about Avandia safety--and apparently so do European regulators. This week the European Medicines Agency was expected to entertain recommendations on future use of the
Merck suffers as CHMP nixes Erbitux use
It was a bad news-bad news sort of day for Merck KGaA. European regulators unexpectedly rejected the company's Erbitux cancer treatment as a remedy for non-small cell lung cancer. And the company
Avastin, Januvia and more get CHMP nods
A slew of regulatory news out of Europe today as the European Medicines Agency weighs in on a laundry list of new drugs and new indications for old ones. Here's a roundup, with new indications first.
