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Merck & Co axes Keytruda lung cancer niche amid FDA crackdow...

Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing dat

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FDA clears third emergency COVID-19 vaccine from J&J

The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective.

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FDA reviewer backs J&J COVID jab for emergency OK

Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use au

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Sanofi's immunotherapy Libtayo gets FDA approval in first li...

Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients.

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Seagen and Genmab file 'trojan horse' drug with FDA for cerv...

Seagen and Genmab have announced they have filed their antibody-drug conjugate tisotumab vedotin with the FDA for patients with recurrent or metastatic cervical cancer.

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FDA holds back from action over Xeljanz safety study

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on

Merck & Co axes Keytruda lung cancer niche amid FDA crackdow...

FDA clears third emergency COVID-19 vaccine from J&J

FDA reviewer backs J&J COVID jab for emergency OK

Sanofi's immunotherapy Libtayo gets FDA approval in first li...

Seagen and Genmab file 'trojan horse' drug with FDA for cerv...

FDA holds back from action over Xeljanz safety study

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

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