After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...

The FDA has accepted for review a resubmission of the BLA for bevacizumab-vikg (ONS-5010) for the treatment of wet AMD.

Bristol Myers Squibb BMY announced that it has obtained FDA approval for the label expansion of Opdivo (nivolumab) plus Yervoy (ipilimumab). The regulatory body approved Opdivo plus Yervoy as a ...

Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...

The company stated that the FDA noted at least one additional adequate and well controlled study to demonstrate a positive ...

Many Americans wonder whether the pill used in most U.S. abortions will be restricted under the new Republican administration in Washington. President Donald Trump’s pick to lead the Food and ...

Dr. Daniel George discusses research with postdoctoral fellow Ananya Dutta. This new clinical trial involved a drug called olaparib. The trial led to FDA approval of the drug in combination with ...

Mifepristone’s labeling lists a complication that most medical groups don’t consider a serious or major adverse event: ER visits, which ranged from 2.9% to 4.6%. The current FDA label lists ...

Mifepristone’s labeling lists a complication that most medical groups don’t consider a serious or major adverse event: ER visits, which ranged from 2.9% to 4.6%. The current FDA label lists going to ...