Krystal Biotech's VYJUVEK, a first-mover gene therapy for DEB, has received a positive CHMP recommendation. Read why KRYS ...

European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against a marketing authorization for the drug’s use in early symptomatic Alzheimer’s disease.

Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted a positive opinion for the label expansion of Fabhalta ...

“Today’s positive opinion by the CHMP marks an important step forward in offering a potentially new and differentiated treatment option for people living with this chronic and debilitating ...

The Scientific Advisory Group (SAG) has been called in to assist the EMA’s CHMP human medicines committee ... for a SAG meeting is “a commonly used procedure for new treatments and new ...

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be granted conditional marketing authorisation to treat relapsed and refractory MM in adults who have received ...

The Committee for Medicinal Products for Human Use (CHMP) has also recommended J&J’s Stelara (ustekinumab) to treat paediatric patients weighing at least 40kg with moderately to severely active CD, ...

Eli Lilly and Company LLY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommending approval of its ...

It is the first time that the CHMP has reviewed a medicinal product for the EU market under a centralised procedure simultaneously with a medicinal product for non-EU countries under the ‘Eu ...

The Princeton, N.J., biopharmaceutical company said the European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected by June 2.

CHMP of the European Medicines Agency based its positive opinion on results from the AEGEAN trial. Imfinzi is approved in the US and several other countries in this setting. The company noted that ...

A federal judge has declined to impose sanctions on an attorney who submitted a brief that contained incorrect case citations and quotes generated by artificial intelligence. U.S. District Judge ...