GlobalData on MSN1d
Ultragenyx’s Evkeeza secures EU approval for young children with rare cholesterol disorder
The decision follows a positive recommendation received from the Committee for Medicinal Products for Human Use (CHMP) in ...
GlobalData on MSN12d
AstraZeneca, Daiichi Sankyo withdraw EU application for lung cancer treatment
AstraZeneca and Daiichi Sankyo have withdrawn their marketing authorisation application in the European Union (EU) ...
Acoramidis Receives Positive CHMP Opinion for Treatment of Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of acoramidis in the EU based on positive results from the ...
Daily11d
AstraZeneca Tagrisso approved in EU for patients with unresectable EGFR-mutated lung cancer
Cambridge: AstraZeneca's Tagrisso (osimertinib) has been approved in the European Union (EU) for the treatment of adult ...
Pharmabiz11d
AstraZeneca, Daiichi Sankyo voluntarily withdrawn the MAA in the EU for datopotamab deruxtecan for patients with locally advanced or metastatic NSCLC
AstraZeneca, Daiichi Sankyo voluntarily withdrawn the MAA in the EU for datopotamab deruxtecan for patients with locally advanced or metastatic NSCLC: Cambridge, UK Friday, Decemb ...
AFP13d
Datopotamab Deruxtecan Application in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer Voluntarily Withdrawn
Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatm ...
Pharmabiz21d
EMA’s CHMP committee recommends approval of Biocon Biologics’ Yesintek
Biocon Biologics (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use ...
AstraZeneca pulls EU application for cancer drug
AstraZeneca has pulled its European marketing authorisation application for its non-small cell lung cancer treatment based on ...
AstraZeneca withdraws application for lung cancer drug in EU
AstraZeneca has voluntarily withdrawn its marketing authorisation application with the EU's medicines regulator for its ...
PharmaTimes22d
CSL receives positive opinion for garadacimab in hereditary angioedema
Global biotechnology leader CSL has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on garadacimab, ...