FDA

News

Bayer's finerenone gets FDA nod for diabetic kidney disease

Bayer's big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff compe

News

Aduhelm approval controversy dials up as FDA seeks probe

In another twist to the Aduhelm approval tale, FDA's Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives.

News

FDA whittles back Aduhelm approval amid concern over broad l...

One of the criticisms levelled at the FDA over its approval of Biogen and Eisai's Alzheimer's disease drug Aduhelm was its decision to clear use of the drug in a broader group of patients t

News

AZ, Amgen get speedy FDA review for asthma drug tezepelumab

The FDA has started a priority review of AstraZeneca and Amgen's severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022.

News

FDA rejects Provention's type 1 diabetes drug teplizumab

The FDA indicated something was not well with Provention Bio's filing for type 1 diabetes therapy teplizumab in April when it delayed its review.

News

Novartis tries to rescue stalled inclisiran filing with FDA

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes

Bayer's finerenone gets FDA nod for diabetic kidney disease

Aduhelm approval controversy dials up as FDA seeks probe

FDA whittles back Aduhelm approval amid concern over broad l...

AZ, Amgen get speedy FDA review for asthma drug tezepelumab

FDA rejects Provention's type 1 diabetes drug teplizumab

Novartis tries to rescue stalled inclisiran filing with FDA

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

How to meet your physicians where they are online

FDA

Editor's Picks