The FDA’s decision wasn’t surprising to analysts, as “deficiencies” in an approval application have become somewhat of a prelude to rejection. This year alone saw …
Benlysta’s approval was itself a landmark, being the first such drug approved in decades. Its use has grown slowly and steadily over time, falling just …
Insys Therapeutics said Friday that the Food and Drug Administration issued it a Complete Response Letter rejecting the company’s New Drug Application for Buvaya. The …
Three days into the BIO International convention, the industry group touted breaking the Guinness World Record for the largest business partnering meeting. BIO is hoping …
TherapeuticsMD got a green light from the Food and Drug Administration for TX-004HR, a treatment for moderate-to-severe dyspareunia, or vaginal pain during sexual activity caused …
The Food and Drug Administration announced Wednesday an “innovation challenge” aimed at encouraging the development of medical devices such as digital health applications and …
New therapies that may cure diseases caused by defective genes will get a faster path to approval by U.S. regulators, part of an effort by …
