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

regulatory decisions

Roche Basel Switzerland

Roche’s flu pill Xofluza gains EU approval

EU approval is based on results from three phase 3 studies

- PMLiVE

EMA recommends authorisation of Moderna’s COVID-19 vaccine

European Commission likely to formally approve the vaccine soon

- PMLiVE

EMA launches rolling review of J&J’s COVID-19 vaccine

Vaccine entered phase 3 testing in September

Roche Basel Switzerland

Roche’s flu pill Xofluza moves closer towards EU approval

CHMP recommends drug for approval in the EU

- PMLiVE

Sobi’s Gamifant receives final rejection from CHMP for primary HLH

Committee reiterated previous negative opinion

- PMLiVE

EMA will assess potential COVID-19 vaccine on ‘case by case’ basis

Agency will not specify a minimum level of efficacy, according to Reuters

- PMLiVE

Novartis scores CHMP backing for cholesterol drug Leqvio

Potential first-in-class treatment moves closer to EU approval

- PMLiVE

GSK’s anti-BCMA drug leads crowded CHMP recommendations

Ten new drugs receive positive recommendations for approval

- PMLiVE

In virtual meeting, CHMP backs Sanofi’s myeloma drug Sarclisa

Monthly meeting held remotely for the first time due to COVID-19 pandemic

- PMLiVE

Modest meeting sees only two drugs recommended by CHMP

Lilly’s migraine med Emgality receives negative opinion for label extension

- PMLiVE

GSK seeks EU approval for Trelegy in adult asthma patients

If approved would open up a large market for the triple therapy

- PMLiVE

Givlaari, Rybelsus lead crowded CHMP recommendations

EU regulator delivered 15 positive opinions and no rejections

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links