Food and Drug Administration (FDA)
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Akari Therapeutics, Plc announced that the U.S. Food and Drug Administration has granted orphan drug designation for nomacopan for the treatment of hematopoietic stem cell transplantation-associated thrombotic microangiopathy.
The U.S. Food and Drug Administration (FDA) gave tentative approval to Mylan’s pemetrexed, a generic version of Eli Lilly’s $2 billion lung cancer drug, Alimta.
Zensun USA, Inc., a wholly-owned subsidiary of Zensun Sci & Tech Co. Ltd., Shanghai, announced that the investigation of NEUCARDIN, its Recombinant human neuregulin-1 fragment, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of Chronic Heart Failure (CHF).
In the first two weeks of September there were three scheduled PDUFA dates. One of those dates, for Celgene’s myelofibrosis drug, was approved early. Here’s a look.
The report, which is exaggerated or misinterpreted, appears to have been erroneous and triggered a short stock drop before the company and various analysts responded, calming investors.
The U.S. Food and Drug Administration is warning that some drugs that treat hepatitis C can, in rare cases, actually lead to the worsening of liver function or to live failure in patients with chronic hepatitis C.
CrystalGenomics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CG-745, a clinical stage histone deacetylase (HDAC) inhibitor being developed for several hematologic malignancies and solid tumors, for the treatment of patients with pancreatic cancer.
Oncoceutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for ONC206, allowing the first-in-human trial of the compound. ONC206 is the first of the family of drug candidates, which we call “imipridones”, that possess the same core chemical structure as ONC201.
It takes on average five years before the confirmatory trial is even started.
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