Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

regulatory decisions

- PMLiVE

EMA accepts Otsuka and Astex’s marketing authorisation application for acute myeloid leukaemia treatment 

The application is supported by results from a phase 3 trial demonstrating an exposure equivalence to the current standard of care for AML

EU flag

EMA accepts Mundipharma’s application for invasive candidiasis treatment rezafungin

Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%

- PMLiVE

Bristol Myers Squibb’s Opdualag approved by CHMP for melanoma

If approved by the EC, Opdualag would be the first LAG-3 blocking antibody combination available in Europe

- PMLiVE

AstraZeneca’s Tezspire recommended for approval in the EU by CHMP

The recommendation is for the treatment of severe asthma as an add-on therapy for patients 12 years and above

- PMLiVE

Gilead’s COVID-19 drug Veklury recommends for approval by CHMP

If approved by the EC, Veklury will become the only direct-acting antiviral with full marketing authorisation in the EU

- PMLiVE

AbbVie submits migraine prevention drug to EMA for marketing authorisation

If approved, atogepant would be the first daily oral CGRP receptor antagonist migraine treatment for adults in Europe

- PMLiVE

EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate

It is estimated that infections caused by this respiratory virus lead to over 175,000 hospitalisations and 14,0000 deaths in older people in the US each year

- PMLiVE

AstraZeneca’s COVID-19 vaccine receives EMA approval for use as third-dose booster

Vaxzevria is a ‘viral vector’ vaccine, a technology that is also used to create vaccines for other infectious diseases like flu, HIV and Ebola

- PMLiVE

Positive CHMP opinion issued for PTC Therapeutics’ Upstaza

The treatment for AADC will be the first marketed gene therapy to be administered directly into the brain

EU flag

EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine

The vaccine is currently the only inactivated, whole virus adjuvanted candidate in clinical trials in Europe

- PMLiVE

Biogen retracts EMA application for Alzheimer’s drug Aduhelm

The application was pulled after the CHMP said the data provided was not enough to support a marketing authorisation

- PMLiVE

EMA and ECDC publish advice on fourth doses of mRNA COVID-19 vaccines

The regulators have concluded that there is not enough supporting evidence for an immediate fourth dose

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links