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June 23, 2023
The application reflects guidance from EMA and other major health authorities to provide COVID-19 vaccines better matched to currently circulating sublineages The companies expect to be ready to ship ...
June 23, 2023
-- CHMP recommends approval of the Adtralza pre-filled pen. -- Adtralza is currently available in a 1 ml pre-filled syringe. Administration with the 2 ml...
June 23, 2023
By Robb M. Stewart Gilead Sciences has received a positive response from the European Medicines Agencys Committee for Medicinal Products for Human Use on an additional indication for the use of its antibody-drug conjugate Trodelvy in certain type...
June 23, 2023
(RTTNews) - Gilead Sciences Inc. (GILD) said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
June 23, 2023
By Will Feuer AbbVie said the European Medicines Agencys Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of the pharmaceutical companys migraine treatment, called atogepant. The commit...
June 23, 2023
If approved by the European Commission (EC), atogepant will be the first and only once daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) in the European Union (EU) for the prophylaxis of migraine in adults who have four or m...
June 23, 2023
By Adriano Marchese Amylyx Pharmaceuticals said its treatment for amytrophic lateral sclerosis has received a negative opinion from European Union...
June 23, 2023
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a negative opinion regarding Amylyx Pharmaceuticals Inc's (NASDAQ: AMLX) conditional marketing authorization of AMX0035 (Albrioza) for 
June 23, 2023
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a negative opinion regarding Amylyx Pharmaceuticals Inc's (NASDAQ: AMLX) conditional marketing authorization of AMX0035 (Albrioza) for amyotrophic lateral sclerosis (ALS). The CHMP's opinion is contrary to the positive approvals from the FDA and Health Canada based on the strength of the CENTAUR trial data. Amylyx disagrees with the CHMP's opinion and plans to request a formal re-examin...