Medications

FDA Approves Gemtesa

FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB) IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Dec. 23, 2020– Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg Gemtesa (vibegron), a beta-3 adrenergic receptor (β3) agonist, […]

Medications

FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis

South San Francisco, CA — December 14, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for Ocrevus® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have […]

Medications

Simponi Aria (golimumab) Approved by the FDA for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older

HORSHAM, PA, September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria (golimumab) for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population. “This […]

Medications

Selinexor for multiple myeloma receives accelerated FDA approval

A first-in-class drug recently granted accelerated approval by the U.S. Food and Drug Administration (FDA) for adult patients with heavily pretreated multiple myeloma has been the subject of study at Moffitt Cancer Center for years. Now, selinexor (XPOVIO, Karyopharm Therapeutics) used in combination with the corticosteroid dexamethasone will offer another option for patients with multiple […]

Medications

Imbrium Therapeutics Announces FDA Orphan Drug Designation for Tinostamustine for The Treatment of T-Cell Prolymphocytic Leukemia

STAMFORD, Conn. – March 28, 2019 – Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its investigational drug tinostamustine, a potentially first-in-class alkylating deacetylase inhibiting molecule […]