FDA granted orphan drug status to tazemetostat, an EZH2 inhibitor developed by Epizyme Inc., for malignant rhabdoid tumors.
FDA granted orphan drug designation to antifungal drug candidate CD101 IV, developed by Cidara Therapeutics Inc., for the treatment of candidemia and invasive candidiasis. The seven-year period of marketing exclusivity provided through orphan designation combined with an additional five years of marketing exclusivity provided from the previously announced QIDP designation gives CD101 IV for a... […]
The Mayo Clinic in Jacksonville, Fla. will collaborate with Morphotek Inc., a subsidiary of Eisai Inc., in a clinical study in patients with folate receptor alpha positive, triple-negative breast cancer.
FDA issued a complete response letter to a Biologics License Application submitted by Telesta Therapeutics Inc. for MCNA. FDA said that additional phase III clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety.
Venetoclax received its third Breakthrough Therapy Designation from the FDA, for a combination treatment with hypomethylating agents for patients with untreated acute myeloid leukemia who are ineligible to receive standard induction therapy.
FDA granted accelerated approval to a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.
FDA approved Zepatier (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus genotype 1 or 4 infection, with or without ribavirin, following priority review.
FDA approved Halaven (eribulin mesylate) Injection for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen, following priority review.
FDA granted accelerated approval to a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.
FDA granted a Breakthrough Therapy Designation to venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia.
