The US Food and Drug Administration (FDA) recently published ... on analogous intermediate “clinical endpoint.” Because the pathway requires the approval to be based on such a surrogate ...

Earlier this year, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) ...

The FDA has made it clear that the primary bar for NTM drug approval is patient ... seek FDA input on our selection of QOL-B as the new primary efficacy endpoint prior to unblinding the Phase ...

The approval, granted by Ukraine's ... Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, as well as Orphan Drug Designation from the European ...

The MIRACLE study will test a new treatment for AML by combining a standard drug (HiDAC) with either a placebo or two different doses of Annamycin, as recommended by the FDA. The trial will start ...

OSAKA, Japan & WALTHAM, Mass.--(BUSINESS WIRE)--Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced that the U.S ...