FDA

News

FDA sets April date for verdict on Incyte's vitiligo drug

Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo.

News

Califf breezes through Senate nomination hearing

Robert Califf looks set to take a second term as FDA commissioner after navigating a relatively placid two-hour confirmation hearing in the US Senate, with just a few ripples of discontent

News

BMS' Orencia gets FDA nod for GvHD thanks to real-world data

Bristol-Myers Squibb's rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem cell transpl

News

Ardelyx’s-ambition-to-revolutionise-kidney-treatment

FDA advisors unconvinced by Reata's kidney disease drug

An FDA advisory committee has delivered a blow to Reata Pharma, after voting unanimously that the drugmaker's data on bardoxolone – a drug for kidney disease – did not show it is effective.

News

AZ's antibody first to be cleared by FDA for COVID preventio...

AstraZeneca's antibody cocktail for COVID-19, now called Evusheld, has become the first drug in the class to be authorised for prevention of infection by the US FDA.

News

Merck claims another adjuvant okay from FDA for Keytruda

Merck & Co's strategy of pushing Keytruda earlier in the treatment pathway for cancers has secured anther victory, after the FDA approved the immunotherapy for adjuvant treatment of ski

FDA sets April date for verdict on Incyte's vitiligo drug

Califf breezes through Senate nomination hearing

BMS' Orencia gets FDA nod for GvHD thanks to real-world data

FDA advisors unconvinced by Reata's kidney disease drug

AZ's antibody first to be cleared by FDA for COVID preventio...

Merck claims another adjuvant okay from FDA for Keytruda

Biotech is back, with Craig Ackerman

Using AI-driven synthetic personas to take your insights fur...

FDA

Editor's Picks