Keyword: European Medicines Agency (EMA)

Chemistry & Life Sciences

The Success Story of Biosimilars

13.09.2023 -

With their triumphant advance, biosimilars are also setting in motion the usual market mechanisms. Biopharma interest groups warn against the automatic substitution of...


EMA Reviewing Approval of Novartis’ Adakveo

31.01.2023 -

The European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use (CHMP) has begun reviewing its marketing authorization for Novartis’ Adakveo...


AstraZeneca Withdraws US Vaxzevria Launch Plan

16.11.2022 -

AstraZeneca (AZ) has announced it is permanently backing away from any plans to sell its Vaxzevria-branded Covid-19 vaccine in the US.


EMA’s CHMP Greenlights Omicron-1 Vaccines

06.09.2022 -

The human medicines committee (CHMP) of EU drug regulator European Medicines Agency (EMA) has recommended approval of the updated Covid-19 vaccines of Pfizer-BioNTech and...


EMA Gets Ready for Relocation Decision

08.11.2017 - With less than two weeks to go before EU Member States select a new host city for the European Medicines Agency (EMA) on 20 November 2017, the agency is preparing itself to...


EMA Approves AstraZeneca’s Lung Cancer Drug

08.02.2016 - European regulators have approved a lung cancer drug from UK-Swedish drug maker AstraZeneca. Tagrisso was the first new drug to win accelerated approval by the European Medicines...


US Gives Merck’s Antitoxin Priority Review

02.02.2016 - The US Food and Drug Administration (FDA) has granted priority review to US drug maker Merck & Co for bezlotoxumab, an antitoxin for preventing the recurrence of Clostridium...


FDA Accepts Valeant-AstraZeneca Psoriasis Application

29.01.2016 - The US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) submitted by UK-Swedish drugmaker AstraZeneca in partnership with Canadian...