There hasn’t been a new class of drugs approved to help smokers quit since Pfizer's Chantix reached the market nearly two ...
The snacks now have a Class I risk level, meaning there is a "reasonable probability" they could cause "serious adverse ...
Troriluzole failed a phase 3 trial in spinocerebellar ataxia in 2022. Based on talks with the FDA, Biohaven kept tracking ...
The US Food and Drug Administration (FDA) has issued 510(k) clearance to See-Mode Technologies for their AI-based thyroid ...
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not ...
The FDA study involved 40 participants divided into five groups, each receiving either a placebo or escalating doses of ...
Drugmaker Cephalon had the FDA's approval to market these drugs, old under brand names like Actiq, as a sweetened lozenge on ...
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey ...