SGN-1 by Guangzhou Huajin Pharmaceutical Technology for Ovarian Cancer: Likelihood of Approval

FDA on Fri­day pub­lished draft guid­ance lay­ing out its ap­proach to post-warn­ing let­ter meet­ings for gener­ic drug­mak­ers, in­clud­ing the cri­te­ria for grant­i­ng the meet­ings and

Roche’s com­pe­ti­tion in the eye dis­ease space is in­ten­si­fy­ing with Re­gen­eron’s high-dose Eylea and a loom­ing biosim­i­lar chal­lenge, but the Swiss phar­ma said its block­buster