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

regulatory decisions

- PMLiVE

BMS/AZ’s diabetes drug among CHMP recommendations

Xigduo one of six new drugs backed in EU

Biogen Idec building

Biogen Idec wins EU battle on Tecfidera exclusivity

Oral MS drug gains New Active Substance status

- PMLiVE

CHMP recommends Gilead’s sofosbuvir for hep C

Set to be first interferon-free treatment regime

- PMLiVE

CHMP names France’s Pierre Demolis vice-chair

He is director of the oncology and haematology division at the ANSM

Roche - Basel

Roche’s Kadcyla and Bayer’s Xofigo near EU approval

Cancer drugs receive CHMP backing

- PMLiVE

EMA backs drugs from Novo, Otsuka, AZ, Janssen, GSK

Nine new branded medicines recommended for use in Europe

- PMLiVE

Boehringer’s first cancer drug leads EMA recommendations

Afatinib recommended for lung cancer under brand name Giotrif

- PMLiVE

Pfizer and Otsuka face drug rejections in Europe

EMA turns down Xeljanz for rheumatoid arthritis and delamanid for tuberculosis

- PMLiVE

GSK’s personalised cancer drug Tafinlar set for European approval

Regulatory advisors recommend the melanoma drug be licensed

- PMLiVE

First mAb biosimilars set for European approval

Celltrion and Hospira's versions of J&J's blockbuster Remicade recommended by CHMP

- PMLiVE

EMA backs Pomalidomide Celgene in multiple myeloma

Further positive CHMP opinions for new medicines form Aegerion, Teva and more

- PMLiVE

GSK/ Valeant’s Trobalt set for EU restrictions

Eye concerns prompt CHMP to recommend last-line use for the epilepsy drug

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links