Spero Therapeutics announced that the Food and Drug Administration (FDA) has granted Fast Track designation for SPR994 (tebipenem pivoxil hydrobromide) for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP)
US WorldMeds announced that the Food and Drug Administration (FDA) has approved the reintroduction of Zelnorm (tegaserod) for the treatment of irritable bowel syndrome with constipation (IBS-C) in women aged <65 years.
EMD Serono announced that the Food and Drug Administration (FDA) has approved Mavenclad (cladribine) tablets for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS).
Boehringer Ingelheim and Lilly announced preliminary data from the EMPRISE ( EMPagliflozin compaRative effectIveness and SafEty) real-world study at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting 2019 in San Diego.
Luye Pharma Group announced the submission of a New Drug Application (NDA) for Rykindo (risperidone extended-release microsphere; LY03004) for Injectionto the Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar disorder.
Gilead Sciences and Galapagos NV announced that filgotinib met the primary and major secondary endpoints in the phase 3 FINCH 1 rheumatoid arthritis, as well as the primary endpoint in the phase 3 FINCH 3 study in methotrexate (MTX)-naive rheumatoid arthritis patients.
The FDA has approved Cimzia (certolizumab pegol; UCB) injection for the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, the first treatment approved for this condition.
Janssen announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Invokana (canagliflozin) to reduce the risk of end-stage renal disease and renal or cardiovascular (CV) death in adults with type 2 diabetes and chronic kidney disease.
The Food and Drug Administration (FDA) has approved Jatenzo (testosterone undecanoate; Clarus Therapeutics) capsules for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Velicept Therapeutics announced that solabegron met the primary endpoint in the phase 2b VEL-2002 study that evaluated patients with overactive bladder (OAB).
