.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 »

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 »

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 »

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 »

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 »

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 »

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

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 »

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 »

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 »

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the European Medicines Agency (EMA) has completed formal validation of Acorda’s Marketing Authorization Application (MAA) for INBRIJA. Read More »

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Read More »