May 29 (Reuters) - Replimune said on Friday it plans to apply a third time for approval of its experimental skin cancer drug ...

Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.

A device called the Optilume is helping to reduce the risk of recurring scar tissue in patients with urethral strictures, said Dr. Ryan Donahue, a urologist at Resolute Baptist Hospital in New ...

FDA Commissioner Marty Makary defended himself in an interview with CNBC's David Faber. Makary has come under pressure for recent drug rejections. One of the most high-profile examples is the FDA's ...

The product combining adapalene 0.1% and benzoyl peroxide 2.5% was approved as a prescription acne treatment in December 2008 ...

The U.S. Food and Drug Administration has approved Taiho Oncology's Inqovi (decitabine and cedazuridine) plus venetoclax for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) ...

A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance ...

BeOne Medicines has entered the BCL-2 arena, securing an FDA green light for Beqalzi that carves out a unique piece of territory ahead of a potential broader clash with market leader Venclexta. The ...

May 6 (UPI) --The Food and Drug Administration approved some flavored vapes delivering on a campaign promise from President Donald Trump to "save vaping." The FDA gave its OK to electronic cigarettes ...

The FDA has authorized four new electronic nicotine delivery system (ENDS) products for sale in the U.S., bringing the total number of authorized vaping products to 45. The newly approved products ...

The Food and Drug Administration (FDA) on Tuesday approved marketing for four flavored vapes made by the company Glas Inc. in what the agency says is an effort to tamp down on underage use of these ...

Four flavored vapes have been approved by the U.S. Food and Drug Administration days after a pressure campaign from President Donald Trump, a new report claims. Trump then asked his advisers Monday ...