Pharmafile Logo

Raxone

EU flag

Wakix backed for European approval in narcolepsy

Bioprojet Pharma’s orphan drug given a positive opinion by CHMP

- PMLiVE

Amgen’s Imlygic recommended for European approval

First-in-class oncolytic immunotherapy wins CHMP positive opinion

EU flag

CHMP October meeting gives recommendations for Pfizer and MSD

But the regulatory advisors sound note ofcaution on Biogen’s Tecfidera

- PMLiVE

Novartis’ Cosentyx on course for new European indications

CHMP recommends its approval to treat ankylosing spondylitis and psoriatic arthritis

EU flag

CHMP recommends 19 new medicines for European approval

Praxbind and Entresto - both fast-tracked - among those to be backed

- PMLiVE

Amgen’s Kyprolis and Blincyto on track for European approval

Double CHMP recommendation backs the myeloma and leukaemia drugs

- PMLiVE

CHMP backs GSK’s asthma antibody and Novartis’ heart failure drug

Positive opinions for GSK's IL-5 antibody and Novartis' potential $5bn-a-year brand

EU flag

Three cancer immunotherapies amongst new CHMP approvals

BMS’ Evotaz also amongst eight new medicine recommendations

Bristol-Myers Squibb (BMS) building

BMS’ Opdivo backed as melanoma therapy in EU

First checkpoint inhibitor to be recommended for approval in the region

EISAI

Eisai’s thyroid cancer drug Lenvima nears EU approval

Positive recommendation by the CHMP could see the orphan drug used in Europe within three months

EU flag

New cancer meds and drug extensions top CHMP recommendations

Drugs for rare disease, oncology and diabetes top regulator’s endorsements

EU flag

Jinarc backed for European approval in rare kidney disease

Positive opinion for Otsuka comes just before rare disease awareness day

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links