Availability of diphtheria antitoxin through an Investigational New Drug
Vivacelle Bio provided support for the investigational new drug
application to the US Food and Drug Administration for a phase IIa clinical trial of VBI-S.
Stem cell company StemCyte revealed on Thursday the receipt of the US Food and Drug Administration's (FDA) approval for the start of its Phase II Investigational New Drug
(IND) application for Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical Cord Blood Mononuclear Stem Cells (UCBMNC) (MC001) for treating spinal cord injury.
The company is in the process of filing an Investigational New Drug
(IND) application for this product in India and it plans to conduct multiple clinical trials as part of the IND protocol.
The company plans to file an investigational new drug
application with the Food and Drug Administration later this year.
Usman says Sirna expects to file an investigational new drug
application with the U.S.
The FDA has revised its guidance on Investigational New Drug
(IND) exemptions for marketed cancer drugs to allow some large randomized trials to qualify.
Incara Pharmaceuticals, Inc., Research Triangle Park, NC, announced the US Food and Drug Administration (FDA) has allowed their Investigational New Drug
Application (IND) to begin Phase I clinical trials of cryopreserved human liver cells for the treatment of patients with cirrhosis and end-stage liver disease.
In the proposed New York bill, for example, coverage would be mandated for patients enrolled in clinical trials if, among other things, the trials have been approved by the Food and Drug Administration as part of investigational new drug
Several FDA-approved Investigational New Drug
studies have demonstrated its value as such, and in some cases its advantages over THC pills.
CymaBay Therapeutics announced FDA clearance of the company's Investigational New Drug
Application or seladelpar to treat primary sclerosing cholangitis.
M2 PHARMA-February 12, 2019-BioArctic reports approval by US FDA of Investigational New Drug
Application for ABBV-0805