Amgen Inc. (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved XGEVA™ (denosumab), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was approved following a 6...
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) has approved EGRIFTA™ (tesamorelin for injection) as the first and only treatment indicated to reduce excess abdominal fat in HIV-infected patients with lipodystrophy...
Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) announced the U.S. Food and Drug Administration (FDA) has approved Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS), an ultra-rare orphan disorder...
The U.S. Food and Drug Administration approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month. "Chronic migraine is one of the...
The Arthritis Foundation announces a major step in passing bi-partisan arthritis legislation in more than 30 years. The Arthritis Prevention, Control and Cure Act (H.R. 1210/S. 984) was approved today by the House Energy and Commerce Committee and will now go to the House of Representatives to...
The U.S. Food and Drug Administration approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg). Levomefolate calcium is a metabolite of folic acid, a water-soluble B-vitamin that helps produce and maintain new cells in...
Bayer HealthCare Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive (OC), Beyaz™ (drospirenone / ethinyl estradiol / levomefolate calcium tablets and levomefolate calcium tablets). Beyaz is the first and only OC approved to...
The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS). "Gilenya is the first oral drug that can slow the progression of disability and reduce the...
Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced that the U.S. Food and Drug Administration (FDA) accepted the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate, Menerba®, in a Type "B" or "End of Phase 2" meeting. With this designation, the decisions and...
The Washington Post: "Virginia Attorney General Ken Cuccinelli II has concluded that the state can impose stricter oversight over clinics that perform abortions, a move immediately decried by abortion-rights organizations and others as an attempt to circumvent the General Assembly, which has...
Kenya on Thursday announced that voters overwhelmingly approved a new constitution, despite objections from religious leaders over abortion rights and other issues, the New York Times reports. The final results of Wednesday's referendum showed that 67% of Kenyans supported the constitution...
Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or...
Roche Molecular Diagnostics (SIX: RO, ROG: OTCQX: RHHBY) announced that the Food and Drug Administration (FDA) approved its new dual-PCR target HIV-1 viral load test to quantify the amount of virus in a patient's blood. The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 is the first...
The US FDA (Food and Drug Administration) has lifted a clinical hold on Geron's Investigational New Drug (IND) application - the Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may now go ahead. GRNOPC1 is the first ever clinical trial of a human embryonic stem cell...
On Tuesday, the Senate Judiciary Committee voted 13-6 in favor of Supreme Court nominee Elena Kagan, sending the nomination to the full Senate for consideration, the New York Times reports (Stolberg, New York Times, 7/20). Republican Sen. Lindsey Graham (S.C.) was the only GOP panel member to...
On Monday, Oklahoma County District Judge Noma Gurich approved a temporary injunction blocking enforcement of an abortion restriction law (HB 2780) until litigation over the law is completed, the Oklahoman reports. The law requires women seeking abortion care first undergo an ultrasound. Gurich...
Strativa Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz® (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a...
Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) approval of its Genesys HTA™ System for the treatment of menorrhagia. The Genesys HTA System is a next-generation endometrial ablation system designed to ablate the endometrial lining of the uterus...
The U.S. Food and Drug Administration approved Natazia, a combination hormonal tablet for use as an oral contraceptive. Natazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the United...