Food and Drug Administration (FDA)

NEWS

Policy

FDA Action Alert: Jazz, ANI and Ultragenyx

Wrapping up the month of July, there are three PDUFA dates on the U.S. Food and Drug Administration (FDA) calendar.

July 17, 2020

3 min read

Mark Terry

Policy

Biopharma Update on the Novel Coronavirus: July 17

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 17, 2020.

July 16, 2020

5 min read

BioSpace Editorial Staff

It's a yes for GSK’s multiple myeloma drug belanta

Policy

FDA Advisory Committee Votes 12-0 to Recommend GSK’s Multiple Myeloma Drug Belantamab Mafodotin

“We are pleased the committee recognized the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options,” said Axel Hoos, senior vice president and heat of Oncology R&D for GSK.

July 15, 2020

3 min read

Mark Terry

Policy

Biopharma Update on the Novel Coronavirus: July 15

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 15, 2020.

July 14, 2020

5 min read

BioSpace Editorial Staff

Drug Development

Biopharma Update on the Novel Coronavirus: July 13

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 13, 2020.

July 13, 2020

3 min read

BioSpace Editorial Staff

Policy

Good, But Not Good Enough: FDA Rejects Merck-Eisai Combo for Liver Cancer

The U.S. Food and Drug Administration issued a Complete Response Letter to Merck and Eisai over their Lenvima and Keytruda combination for first-line treatment of unresectable hepatocellular carcinoma (HCC).

July 9, 2020

3 min read

Mark Terry