KalVista Pharmaceuticals, Inc.

Bayer’s hopes of launching elinzanetant onto the US market this summer have been dashed by the US Food and Drug Administration which needs more to time to evaluate the company’s submission for the clo

The European Medicines Agency has recommended that Gilead Sciences’ Yeytuo (lenacapavir), for preventing HIV, and 13 other new drugs should be granted pan-EU marketing authorization, but it has advise

Gilead Sciences’ Yeytuo (lenacapavir) and Eli Lilly’s Kisunla (donanemab) are among the drugs that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for

The US Food and Drug Administration’s oncology review teams are seeing significant attrition, which could impact the speed of approvals and company product launch strategies. The Center for Drug Evalu