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

LHON

- PMLiVE

EMA starts review of Xtandi in non-metastatic prostate cancer

The evaluation is based on positive results from the PROSPER trial

- PMLiVE

Bad news for Portola as CHMP considers Factor Xa drugs

The committee are ‘unlikely’ to adopt a positive opinion for betrixaban

- PMLiVE

EMA’s Amsterdam home will not be ready in time

Staff will initially move to a temporary building in the city after Brexit

- PMLiVE

CHMP hands Santhera second ‘no’ in Duchenne muscular dystrophy

Swiss biopharma says it will re-file Raxone for the licence extension

- PMLiVE

EMA hands UniQure orphan status first in Huntington’s

The Dutch biotech expects to file the treatment for approval later this year

- PMLiVE

Novartis gets speedy reviews for new Kymriah filings

US and EU regulatory agencies will review the drug for DLBCL patients

AstraZeneca AZ

AZ speeds first-line lung cancer filing for Tagrisso to EMA

As FLAURA trial results show boosted progression-free survival

- PMLiVE

EMA forges closer ties with HTA umbrella group

Agrees joint work plan with the European Network for Health Technology Assessment

- PMLiVE

Amsterdam picked to host the European Medicines Agency

But regulator faces a “challenging” relocation project to depart from London

- PMLiVE

Merck pulls Keytruda filing in Europe, despite US approval

Phase II KeyNote-0241 trial results failed to win over the EMA

- PMLiVE

CHMP recommends Teva’s generic version of Astellas’ Advagraf

Committee backs the drug for transplant rejection prophylaxis

Roche Basel Switzerland

Roche wins CHMP nod for Alecensa licence extensions

Lung cancer monotherapy set for a broader European label

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links