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© 2022 MJH Life Sciences and BioPharm International. All rights reserved.
© 2022 MJH Life Sciences™ and BioPharm International. All rights reserved.
March 15, 2022
As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.
March 04, 2022
EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.
February 28, 2022
EMA has recommended approval of Spikevax for children aged 6 to 11.
February 16, 2022
The agency recommended 53 new active substances in 2021, up 35% from 2020.
The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.
Guidance published during the pandemic has been updated to include content requirements for summary safety reports.
February 11, 2022
EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.
EMA has started the establishment of its Data Analysis and Real World Interrogation Network (DARWIN EU) Coordination Centre.
January 19, 2022
The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.
December 20, 2021
The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.