FiercePharma6d
Merck vaccine, Daiichi ADC win approval recommendations in busy week at EU's drug regulator
Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...
AstraZeneca: CHMP Recommends Approval Of Imfinzi In The EU
AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and only immunotherapy ...
Business Wire23d
Acadia Pharmaceuticals Submits Marketing Authorization Application to the European Medicines Agency for Trofinetide for the Treatment of Rett Syndrome
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency ...
precisionmedicineonline6d
CHMP Recommends European Approval for AstraZeneca, Daiichi Sankyo's Datroway in Breast Cancer
The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.
MercoPress3y
Novavax added to COVID-19 immunizers approved for European use
The US-developed NOVAVAX vaccine against COVID-19 has been approved Monday by the European Medicines Agency (EMA), thus becoming the fifth drug of its kind to become available at a continental level.
Business Wire1mon
CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union
ZUG, Switzerland--(BUSINESS WIRE)--Galderma today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ... s approval for subcutaneous use ...