FDA

News

Tagrisso-chemo cleared in US as 1st-line lung cancer therapy

AstraZeneca’s Tagrisso can be used alongside chemotherapy as a frontline therapy for EGFR-positive non-small cell lung cancer (NSCLC), according to the FDA, consolidating

News

FDA turns down Satsuma’s nasal migraine treatment

Manufacturing problems have scuppered Satsuma Pharmaceuticals’ chances of a timely FDA approval for its intranasal migraine therapy STS101.

News

Keytruda breaks new ground in cervical cancer

MSD’s checkpoint inhibitor Keytruda has been cleared by the FDA for use in newly diagnosed cervical cancer patients with less severe disease, becoming the first anti-PD-1/

News

FDA seeks feedback on digital tools for diabetes

The FDA has opened a comment period, extending until the end of the month, that is seeking information on how digital health technologies (DHTs) might be deployed to help

News

FDA finds no link between GLP-1 drugs and suicide

The FDA has given an update on its ongoing review of a possible link between GLP-1 agonist drugs used to treat diabetes and obesity and suicide, saying it can find no evid

News

FDA blocks Astellas’ Claudin cancer drug over manufacturing

Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted drug can

Tagrisso-chemo cleared in US as 1st-line lung cancer therapy

FDA turns down Satsuma’s nasal migraine treatment

Keytruda breaks new ground in cervical cancer

FDA seeks feedback on digital tools for diabetes

FDA finds no link between GLP-1 drugs and suicide

FDA blocks Astellas’ Claudin cancer drug over manufacturing

GBL joins CVC in €10.7bn takeover bid for Recordati

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

FDA

Editor's Picks