FDA cracks down on sales of Juul tobacco products to minors
(Reuters) – The U.S. Food and Drug Administration on Tuesday said it launched a crackdown on the sale of e-cigarettes and tobacco products to minors, particularly those developed by Juul…
FDA declines to approve Pfizer’s biosimilar to Roche’s cancer drug
(Reuters) – Pfizer Inc said on Monday the U.S. Food and Drug Administration (FDA) declined to approve the company’s biosimilar to Roche’s breast cancer drug, Herceptin, and sought additional technical…
FDA approves Ultragenyx’s drug for rare form of rickets
(Reuters) – The U.S. Food and Drug Administration has approved Ultragenyx Pharmaceutical Inc’s treatment for a rare and inherited form of rickets, a condition that causes weak bones, the agency…
FDA refuses to review Alkermes’ depression treatment, seeks more trials
(Reuters) – Alkermes Plc has been told to conduct more clinical trials of its experimental depression treatment after the U.S. Food and Drug Administration rejected its initial application for approval,…
FDA panel backs Pfizer’s Xeljanz as bowel disease treatment
(Reuters) – Pfizer Inc’s Xeljanz should be approved to treat patients with moderate to severe ulcerative colitis, a chronic bowel disease, a U.S. Food and Drug Administration (FDA) advisory committee…