Approvals

Versantis receives FDA rare paediatric disease designation for VS-01 to treat urea cycle disorders

Versantis AG, a clinical-stage company developing novel therapies for orphan liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a rare pediatric disease designation (RPDD) to its lead product candidate VS-01, an ammonia clearance enhancer, for the treatment of Urea Cycle Disorders (UCD).

Genentech announces full FDA approval for Venclexta combinations for acute myeloid leukemia

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

FDA approves expanded indication for Merck’s KEYTRUDA in adult patients with relapsed or refractory cHL

Merck announced that the US Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

Regeneron’s Inmazeb gets FDA approval for Ebola treatment

Regeneron Pharmaceuticals’ antibody cocktail Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) has been approved by the US Food and Drug Administration (FDA) for the treatment of Zaire ebolavirus (Ebola virus).

Ocular Therapeutix announces topline phase 1 clinical trial results of OTX-CSI

Ocular Therapeutix, a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced topline Phase 1 clinical trial results of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).

FDA grants GlycoMimetics rare paediatric disease designation for rivipansel for treatment of sickle cell disease

GlycoMimetics announced that the U.S. Food and Drug Administration (FDA) has granted the Company a Rare Pediatric Disease designation for rivipansel for the treatment of sickle cell disease in patients 18 years old and younger. This designation recognizes the significant needs in pediatric patients.

ImmunoGen gets FDA breakthrough therapy status for IMGN632 to treat relapsed or refractory BPDCN

ImmunoGen has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its IMGN632 to treat patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).

FDA approves Opdivo, Yervoy combo for previously untreated unresectable MPM

Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

Infinity receives fast track designation for eganelisib in combination with checkpoint inhibitor and chemotherapy for advanced TNBC

Infinity Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting. Infinity is currently enrolling patients in MARIO-3, the Company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq and Abraxane in TNBC.