Keyword: European Medicines Agency (EMA)
Chemistry & Life Sciences
13.09.2023
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With their triumphant advance, biosimilars are also setting in motion the usual market mechanisms. Biopharma interest groups warn against the automatic substitution of...
News
31.01.2023
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The European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use (CHMP) has begun reviewing its marketing authorization for Novartis’ Adakveo...
News
16.11.2022
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AstraZeneca (AZ) has announced it is permanently backing away from any plans to sell its Vaxzevria-branded Covid-19 vaccine in the US.
News
06.09.2022
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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...
News
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...
News
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...
News
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...
News
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...