regulatory approval

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Merck pulls Keytruda's FDA nod for third-line stomach cancer

Merck & Co will voluntarily withdraw a US marketing approval for cancer immunotherapy blockbuster Keytruda in gastric cancer, after studies intended to confirm its efficacy in this sett

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Keytruda beats Opdivo to first-line oesophageal cancer OK in...

Merck & Co's Keytruda has become the first cancer immunotherapy to be approved as a first-line oesophageal cancer therapy in the EU, ahead of Bristol-Myers Squibb's rival Opdivo, but BM

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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

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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.

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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.

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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.

Merck pulls Keytruda's FDA nod for third-line stomach cancer

Keytruda beats Opdivo to first-line oesophageal cancer OK in...

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

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

regulatory approval

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