news
EMA’s human medicines committee (CHMP) September meeting highlights
In its most recent meeting, the CHMP recommended nine new medicines and concluded its review of Vaxzevria’s thrombosis risk.
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European Medicines Agency (EMA)
news
EMA evaluates data on Comirnaty® COVID-19 vaccine booster dose
EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.
news
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
news
EC approves Ultomiris for children and adolescents with PNH
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
news
FDA application to be submitted for Comirnaty® booster dose
Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.
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Comirnaty and Moderna COVID-19 vaccine supply to increase in the EU
The CHMP has adopted recommendations to increase manufacturing capacity and supply of COVID-19 Vaccines Comirnaty and Moderna in Europe.
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Evrenzo™ approved for CKD-related anaemia treatment in EU
The European Commission (EC) has approved Astellas’ Evrenzo™ for adult patients with symptomatic anaemia of chronic kidney disease (CKD).
news
Abecma is the first treatment approved by EC for multiple myeloma
The European Commission (EC) has approved Abecma, the first anti-BCMA CAR T-cell therapy for patients with multiple myeloma.
news
MHRA approves COVID-19 Vaccine Moderna in 12-17-year olds
The MHRA has approved the use of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) in children aged 12-17 years old.
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ICMRA set out recommendations for AI regulation in medicine
The ICRMA has set out recommendations to help regulators tackle the challenges posed by artificial intelligence (AI) in medicine.
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EMA endorses global facilitation of track and trace systems
The European Medicines Agency has endorsed ICMRA recommendations to facilitate the use of track and trace systems for medicinal products at a global level.
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EMA’s human medicine committee (CHMP) meeting highlights, July 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
podcasts
EPR Podcast Episode 1 – Richard Daniell, Teva Pharmaceuticals
Learn about current and future European pharmaceutical supply chains from Richard Daniell at Teva Pharmaceuticals in European Pharmaceutical Review’s first podcast.
article
EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
news
Marketing of Zynteglo suspended as precaution due to potential cancer risk
bluebird bio has chosen to suspend sales of Zynteglo while they investigate whether safety concerns identified with a related investigational gene therapy may apply to the licenced medicine.
