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FDA rejects Novo Nordisk’s weekly basal insulin

Novo Nordisk’s bid to provide a once-weekly basal insulin product for people with diabetes, reducing the number of injections needed, has hit a major hurdle in the US.

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6th Gene Therapy Analytical Development & CMC Summit

Execute Robust Analytical & Process Development Strategies for Complex Gene Therapies

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FDA turns down MSD, Daiichi Sankyo HER3 ADC for lung cancer

The FDA has said it cannot approve MSD and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate (ADC) patritumab deruxtecan because of problems at a third-party manufacturer.

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FDA reveals diversity action plan guide for clinical trials

The FDA has published its long-awaited update to guidance to make sure clinical trials more closely reflect the range of patients that might be treated with a new therapy in the real world.

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Sarepta bags key expansion to DMD gene therapy label in US

Sarepta’s gene therapy for Duchenne muscular dystrophy (DMD) will be an option for many more patients in the US after the FDA expanded the breadth of its approved labelling.

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KalVista files first oral on-demand HAE drug with FDA

KalVista Pharma has filed its first marketing application to the US FDA, seeking approval for its oral plasma kallikrein inhibitor sebetralstat as an oral treatment for hereditary angioedem

FDA rejects Novo Nordisk’s weekly basal insulin

6th Gene Therapy Analytical Development & CMC Summit

FDA turns down MSD, Daiichi Sankyo HER3 ADC for lung cancer

FDA reveals diversity action plan guide for clinical trials

Sarepta bags key expansion to DMD gene therapy label in US

KalVista files first oral on-demand HAE drug with FDA

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

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