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...

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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...

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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.

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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...

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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...

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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...

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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...

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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...