regulatory approval

News

AZ, MSD's Koselugo is first EU therapy for neurofibromatosis

The European Commission has approved AstraZeneca and MSD's Koselugo for a rare genetic condition that causes tumours to develop on the covering of nerve cells, leading to disfigurement and

News

FDA looks at pulling speedy approvals for three cancer drugs

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market.

News

MHRA approves Seagen’s oral HER2 drug Tukysa

The UK drugs regulator has approved Seagen’s Tukysa as a third-line treatment for HER2-positive breast cancer, shortly after it was given a green light by the European Commission.

News

Sobi gets EU nod for Doptelet in rare blood disorder ITP

Sweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the company expects to accelerate sales of the drug.

News

Roche claims EU okay for Herceptin/Perjeta combination Phesg...

Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer to patients – and also provides

News

Vertex gets EU okay to treat younger cystic fibrosis patient...

A new EMA approval has expanded the use of Vertex Pharma’s cystic fibrosis therapy Symkevi to children as young as six if they have specific gene mutations.

AZ, MSD's Koselugo is first EU therapy for neurofibromatosis

FDA looks at pulling speedy approvals for three cancer drugs

MHRA approves Seagen’s oral HER2 drug Tukysa

Sobi gets EU nod for Doptelet in rare blood disorder ITP

Roche claims EU okay for Herceptin/Perjeta combination Phesg...

Vertex gets EU okay to treat younger cystic fibrosis patient...

On genomics, NGS, and doing much more good than bad, with Ma...

How to meet your physicians where they are online

regulatory approval

Editor's Picks