By Sruthi Narasimha Chari and Christy Santhosh June 11 (Reuters) - Wall Street has pushed to next year expectations for a U.S. approval for Camurus' drug to treat a rare hormonal condition after the health regulator's second refusal on Wednesday.

Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) earlier this week announced that the US Food and Drug Administration (FDA) granted Fast Track Designation to its allogeneic CAR T therapy azer-cel for relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) and

The six-page FDA memo suggests regulators sidestepped previous concerns about the risks associated with sweet vaping flavors

Amgen Inc. has engaged an independent academic organization to reevaluate data for a rare disease drug that US regulators are trying to pull from the market.

June 11 (Reuters) - The U.S. Food and Drug Administration on Thursday authorized the emergency use of a generic over-the-counter tablet to treat infestations caused by the New World screwworm in dogs and cats,

Ned Sharpless, a first-term Trump health official who has criticized vaccine policies championed by Robert F Kennedy Jr., is being considered for FDA commissioner.

Bemotrizinol (PARSOL Shield), an advanced sunscreen filter that has long been used in Europe and Asia, has been approved for use in the U.S. by the FDA.

Metal contamination frozen snack recall: A popular frozen snack, Farm Rich Pizza Cheese Crunchers, is being recalled. The US Food and Drug Administration announced the recall due to potential metal pieces.