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

betrixaban

- 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

Pfizer’s Paxlovid receives positive opinion from CHMP

If authorised, the drug would be the first COVID-19 oral treatment recommended in the EU

- PMLiVE

Gilead’s Trodelvy approved for triple-negative breast cancer in Europe

European patients with metastatic triple-negative breast cancer can now receive the antibody-drug conjugate as second-line monotherapy

- PMLiVE

Gilead’s Trodelvy set for EU approval in breast cancer

The positive opinion from EMA’s CHMP means Trodelvy could be available as second-line treatment for unresectable or metastatic breast cancer before the end of the year

Biogen Idec building

Biogen’s Vumerity recommended by CHMP in MS

A thumbs up for Vumerity in the EU could ease the way for Biogen’s follow-up to Tecfidera in multiple sclerosis

- PMLiVE

CHMP rejects Kyowa Kirin’s Parkinson’s disease drug

Results of eight main studies of drug were 'inconsistent', according to the CHMP

- PMLiVE

CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

- PMLiVE

bluebird bio’s CALD gene therapy Skysona gains positive opinion from CHMP

CHMP's marketing authorisation recommendation is a step towards gaining EU approval

- PMLiVE

EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

- PMLiVE

J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

- PMLiVE

EMA starts rolling review of Lilly’s COVID-19 antibodies

CHMP will review the combination of bamlanivimab and etesemivab as well as bamlanivimab monotherapy

- PMLiVE

EMA recommends use of Lilly’s COVID-19 antibody cocktail

Agency concludes bamlanivimab and etesevimab can be used to treat certain COVID-19 patients

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links