Topic: FDA advisory committee
Should the FDA approve Sanofi’s SGLT2 candidate for patients with Type 1 diabetes? Turns out, the experts couldn't agree.
If you thought Amgen osteoporosis candidate Evenity was down for the count, think again.
Amgen's Evenity is trying to score an approval after cardiovascular red flags derailed it in mid-2017. But analysts aren’t so optimistic.
The sublingual Dsuvia can only be administered by a healthcare professional in medically supervised settings such as hospitals.
Pfizer just got some backup on its quest to snag a nod for ulcerative colitis med Xeljanz. On Thursday, an FDA AdComm voted to approve the drug.
Pfizer is counting on a new approval for Sutent, its kidney cancer drug, but an FDA advisory panel isn’t so sure.
Endo's opioid painkiller Opana ER took a hit on Tuesday when an FDA advisory committee decided that the drug’s benefits no longer outweigh its risks.
Pfizer’s stop-smoking drug Chantix may be one step closer to escaping the FDA’s black box. An agency advisory panel narrowly voted in favor of removing the FDA’s most serious warning, which focuses on neuropsychiatric side effects such as suicidal thoughts and depression.