Principal Investigators on treatment protocols that involve an Investigational New Drug (IND) must complete Form FDA 1572, which the sponsor then submits to FDA. Form FDA 1572 is the contract between ...

Little dark things shouldn’t be in vials of a drug, which is why one lot of an injection drug used to deal with low blood pressure under anesthesia got recalled. Provepharm said it pulled lot No.

A non-opioid investigational drug with promising pre-clinical results in treating neuropathic pain has passed an important hurdle after the study's safety review committee (SRC) reviewed the data from ...

A type 1 diabetes patient talked about her successful treatment with an investigational stem cell ... single-dose vials are available for self-pay through LillyDirect, significantly expanding ...

IGM Biosciences announced they are halting the development of two investigational drugs for autoimmune and inflammatory diseases, imvotamab (an IgM-based CD20 X CD3 bispecific antibody T cell engager) ...

Breakthrough Therapy Designation is generally granted to a drug when evidences suggest that the investigational drug may provide substantial improvement over available therapy on at least one ...

The U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin ...

today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company’s investigational UKidney ...

An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy. The term ...