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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

Views & Analysis

Will Gottlieb follow up on Trump's promise of a bonfire of regulations?

Dilemma for Biden as Woodcock’s audition for FDA chief stumb...

The change of administration in the US has also seen a new leader at the FDA, with Dr Janet Woodcock appointed as interim commissioner by president Joe Biden’s new team.

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Incyte makes bid to join the checkpoint inhibitor club

Incyte has filed its PD-1 inhibitor retifanlimab with the FDA, seeking approval to treat a form of anal cancer associated with human papillomavirus (HPV) and HIV infections.

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BMS eyes May FDA verdict for MS drug Zeposia in ulcerative c...

Bristol-Myers Squibb’s commercial hopes for new multiple sclerosis drug Zeposia have yet to bear fruit thanks to the pandemic, but it’s already cued up a second indication for the would-be

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

Dilemma for Biden as Woodcock’s audition for FDA chief stumb...

Incyte makes bid to join the checkpoint inhibitor club

BMS eyes May FDA verdict for MS drug Zeposia in ulcerative c...

GBL joins CVC in €10.7bn takeover bid for Recordati

Discover a new era of healthcare panel engagement: Grounded ...

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