Approvals
The approval marks the first commercial product for Xeris.
The U.S. Food and Drug Administration (FDA) gave the thumbs-up to Boehringer Ingelheim’s Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
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.
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.
Nourianz (istradefylline) was given the thumbs-up as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease who experience “OFF” episodes.
The U.S. FDA gave Nabriva Therapeutics a thumbs-up for both its oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.
AbbVie’s JAK inhibitor Rinvoq was approved by the U.S. Food and Drug Administration for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
The U.S. Food and Drug Administration approved Impact’s Inrebic for the treatment for adult patients with certain types of myelofibrosis, cancers of the bone marrow.
PRESS RELEASES