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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

R&D

Don’t sweat an FDA sIRB mandate in clinical research – It’s ...

We knew it was coming, and now it’s close.

Patients

FDA wants to make the home a healthcare hub

During the pandemic, the world became accustomed to carrying out more activities from the home, including healthcare needs.

News

Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busti

News

Last places on FDA START rare disease programme filled

The last three slots for projects that will be included in the FDA’s new programme to accelerate the development of therapies for rare diseases have been taken by Moderna,

News

Geron finally brings a drug to market as FDA clears Rytelo

More than 30 years after it was first founded, Geron has claimed FDA approval for its first product – myelodysplastic syndromes (MDS) treatment Rytelo.

KalVista files first oral on-demand HAE drug with FDA

Don’t sweat an FDA sIRB mandate in clinical research – It’s ...

FDA wants to make the home a healthcare hub

Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

Last places on FDA START rare disease programme filled

Geron finally brings a drug to market as FDA clears Rytelo

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

How to meet your physicians where they are online

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