GSK today announced it has received approval from the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid (ICS) medicine for the maintenance treatment of asthma in children from as young as 5 years. Read More »

.Pfizer Inc. (NYSE:PFE) announced today that tafamidis received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with transthyretin cardiomyopathy, a rare, fatal, and underdiagnosed condition associated with progressive heart failure.1,2 Read More »

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-407 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC), met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Read More »

A new head-to-head pharmacokinetic study showed that adults with hemophilia B who received a single dose (50 IU/kg) of Rebinyn® [Coagulation Factor IX (Recombinant), GlycoPEGylated] achieved high factor IX activity for longer than those treated with rFIXFc [Coagulation Factor IX (Recombinant), Fc Fusion Protein]. Read More »

HHS Secretary Alex Azar issued the following statement regarding the FDA’s approval of the first non-opioid treatment for the symptoms of opioid withdrawal Read More »

Novartis today announced that the US Food and Drug Administration (FDA) has approved Aimovig™ (erenumab-aooe) for the preventive treatment of migraine in adults. Read More »

The US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalaemia, a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases Read More »

Enrollment has begun in an early-stage clinical trial testing the safety of two human monoclonal antibodies (mAbs) designed to treat people infected with Middle East respiratory syndrome coronavirus (MERS-CoV). Read More »

Prion diseases are slow degenerative brain diseases that occur in people and various other mammals. Read More »

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it will present new data for multiple investigational compounds in the Daiichi Sankyo Cancer Enterprise pipeline at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting from June 1-5 in Chicago. Read More »

United States Attorney Mike Stuart announced that a federal grand jury sitting in Charleston returned a 20-count indictment against Manuel C. Barit, M.D., the only practicing physician at Mullens Family Clinic. Read More »

The New England Journal of Medicine (NEJM) today published detailed results from two Phase 3 trials for the investigational use of Dupixent® (dupilumab) in moderate-to-severe asthma. Read More »

Rite Aid Corporation (NYSE: RAD) announced today that DisposeRx, a first-of-its-kind opioid disposal solution, is now available at all of Rite Aid's more than 2,500 pharmacies across the United States. Read More »

Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers V-Go® Wearable Insulin Delivery device, a simple, all-in-one insulin delivery option for patients with diabetes, announced positive results were shared today from two new studies during poster presentations at the American Association of Clinical Endocrinologists Annual Scientific and Clinical Congress held in Boston, Massachusetts. Read More »

The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Read More »

Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Aimovig™ (erenumab-aooe) for the preventive treatment of migraine in adults. Read More »

Pfizer Inc. (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Read More »

Baxter International Inc. (NYSE: BAX), a leader in innovative technology for medication delivery, today announced the U.S. Food and Drug Administration (FDA) clearance of the Spectrum IQ Infusion System with Dose IQ Safety Software. Read More »

Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S. Read More »

Eli Lilly and Company (NYSE: LLY) announced today that galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period Read More »