On March 19, the Food and Drug Administration granted traditional approval to pembrolizumab, or Keytruda, marketed by Merck (MRK), with ...

Building on our progress this past year, Liquidia has strengthened its financial position, with up to an additional $100 million available pursuant to an amendment to its existing financing agreement ...

Rogaine was approved by the Food and Drug Administration in 1988, the first drug to win the agency’s endorsement for male ...

The future of American drug innovation is threatened by US regulations that permit knockoff versions of new drugs to be sold to US consumers.

FDA accepts Capricor's Biologics License Application for priority review, advancing deramiocel for DMD cardiomyopathy.

The company behind the drug, Sarepta Therapeutics, said that the patient suffered acute liver injury, a known side effect, The Associated Press reported. However, the "severity" of this case had not ...

For the first time, scientists say, they have evidence that using a biologic drug to remove sticky beta amyloid plaques from ...

Johnson & Johnson JNJ announced that the FDA has granted a Fast Track designation (“FTD’) to its investigational drug, ...

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia (denosumab) ...

Traveling to the United States? Before packing your bags, you might want to double-check what you’re bringing along.