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EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.

www.ema.europa.eu

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List of articles in category EMA
Title Published Date
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice 31 March 2022
EMA: Human medicines highlights of 2021 18 February 2022
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines 06 September 2021
AstraZeneca's COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets 07 April 2021
Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna 29 March 2021
EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events 15 March 2021
EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU 11 March 2021
EMA starts rolling review of the Sputnik V COVID-19 vaccine 08 March 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca 12 January 2021
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application 15 December 2020
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2 01 December 2020
EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine 01 December 2020
EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation 30 September 2020
Global regulators commit to cooperate on observational research in the context of COVID-19 21 May 2020
First vaccine to protect against Ebola 28 October 2019
EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US 29 August 2019
EMA to relocate to Amsterdam, the Netherlands 22 November 2017
Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions 29 May 2017
Launch of PRIME - Paving the way for promising medicines for patients 10 March 2016
Human medicines: highlights of 2015 22 January 2016
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Business & Industry

  • Roche enters partnership with the Global Fund to support low- and middle-income countries in strengthening critical diagnostics infrastructure
  • Nearly 700,000 US hospitalizations and 110,000 deaths prevented from the Pfizer-BioNTech COVID-19 vaccine
  • Pfizer and BioNTech provide update on COVID-19 vaccine supply agreement with European Commission
  • Roche pledges to extend commitment to the World Federation of Hemophilia Humanitarian Aid Program to 2028
  • Pfizer to acquire Biohaven Pharmaceuticals

Research & Development

  • "Natural immunity" from omicron is weak and limited, study finds
  • mRNA booster vaccines may be a good investment in developing countries
  • Blocking spike captors to counter COVID
  • Recurring brain tumor growth is halted with new drug
  • Investigational COVID mucosal vaccine protects against disease and transmission
  • Using AI to analyze large amounts of biological data
  • Cognitive impairment from severe COVID-19 equivalent to 20 years of ageing, study finds

Conferences & Events

  • Pharma join together to achieve new standards in digital and patient innovation for clinical transformation
  • SMi's 22nd Annual Pain Therapeutics Conference
  • SMi Group Introduces the 4th Annual Injectable Drug Delivery Conference 2022
  • SMi's 5th Annual Pharmaceutical Microbiology East Coast Conference
  • SMi's 3rd Annual AI in Drug Discovery Conference
  • SMi's 6th Annual Highly Potent Active Pharmaceutical Ingredients
  • SMi's 9th Annual Conference Pre-Filled Syringes East Coast

Regulatory Affairs

  • FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain
  • FDA limits use of Janssen COVID-19 vaccine to certain individuals
  • EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
  • FDA approves first generic of Symbicort to treat asthma and COPD
  • FDA approves treatment for wider range of patients with heart failure
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