Non-Approvable Letter

January 04, 2021

The fate of Celgene security looks to follow that of Genzyme’s

December 02, 2020

US FDA approval tracker: November

November 16, 2020

Sanofi falls at manufacturing hurdle

November 02, 2020

US FDA approval tracker: October

October 02, 2020

US FDA approval tracker: September

October 02, 2020

Mesoblast can’t catch a break

September 17, 2020

Has 2020 been a big year for regulatory knockbacks?

An analysis of FDA complete response letters does not reveal a big uptick – but the year is not over yet.

September 03, 2020

US FDA approval tracker: August

August 21, 2020

Filgotinib was set to struggle, market stats show