Eisai Inc. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental New Drug Application (sNDA) for lenvatinib for the potential first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Read More »

Boehringer-Ingelheim issued the following announcement on May 21.Breckenridge Pharmaceutical, Inc. announced today the supplemental approval for the 40mg strength of Duloxetine Delayed-Release Capsules. Read More »

AstraZeneca and MedImmune, its global biologics research and development arm, today announced positive overall survival (OS) results for the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi (durvalumab) in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT). Read More »

The U.S. Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). Read More »

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia® (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Read More »

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today confirmed that the U.S. Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for fremanezumab, an investigational therapy for the preventive treatment of migraine. Read More »

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the Phase 3 iLLUMINATE (PCYC-1130) trial met its primary endpoint of improvement in progression-free survival (PFS). Read More »

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today full results from the Phase III HAVEN 3 study evaluating HEMLIBRA® (emicizumab-kxwh) prophylaxis administered every week or every two weeks in people with hemophilia A without factor VIII inhibitors and the Phase III HAVEN 4 study evaluating HEMLIBRA prophylaxis administered every four weeks in people with hemophilia A with or without factor VIII inhibitors. Read More »

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 »