The snacks now have a Class I risk level, meaning there is a "reasonable probability" they could cause "serious adverse ...
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not ...
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey ...
The U.S. Food and Drug Administration approved Zevra Therapeutics' drug for a rare and fatal genetic disorder, making it the ...
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 ...
The FDA approval of amivantamab-vmjw (Rybrevant) in combination with chemotherapy is the first targeted treatment to cut ...
Support for the neurokinin-1 receptor (NK1R) antagonist included a negative phase III trial and a positive phase II study ...