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 […]

Medications

FDA Approves Jatenzo

March 27, 2019 — The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland. Jatenzo should […]

Medications

Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients

DUBLIN, March 18, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam), expanding the label to include pediatric patients 3 months and older for the treatment of complicated intra-abdominal infections (cIAI) in combination […]

Health News

FDA Aims to Strengthen Sunscreen Rules

THURSDAY, Feb. 21, 2019 — The U.S. Food and Drug Administration took steps Thursday to tighten regulation of over-the-counter sunscreen products. Included in the proposed rule are updates on sunscreen safety, sun protection factor (SPF) requirements, and the effectiveness of insect repellent/sunscreen combinations. “The proposed rule that we issued today would update regulatory requirements for […]