News Releases
Teva and Active Biotech Report Positive Results from Phase IIa Study of Laquinimod in Active Lupus Nephritis
Teva Pharmaceutical Industries Ltd. and Active Biotech announced today the results of a Phase IIa study of oral laquinimod designed to assess safety, tolerability and clinical efficacy in patients with active lupus nephritis, one of the most serious manifestations of systemic lupus erythematosus (SLE or lupus) that can lead to chronic kidney failure.
New Influenza Vaccine from Sanofi Pasteur Now Licensed by FDA
Sanofi Pasteur, the vaccines division of Sanofi announced today that the US Food and Drug Administration has approved the supplemental biologics license application (sBLA) for licensure of its four-strain influenza vaccine, Fluzone Quadrivalent vaccine.
Intercell Announces Pediatric Approval of its Japanese Encephalitis Vaccine in the US
Intercell AG announced today that the pediatric indication for IXIARO ® , a vaccine to protect against Japanese encephalitis (JE), was approved by the US Food and Drug Administration (FDA).
Novartis Rx Ilaris Approved by FDA
Novartis announced today that the US Food and Drug Administration (FDA) has approved Ilaris ® (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older.
Lipid Lowering Med Liptruzet Now FDA Approved
Merck, known as MSD outside the United States and Canada, today announced that the US Food and Drug Administration (FDA) has approved LIPTRUZET™(ezetimibe and atorvastatin) tablets.
Merck’s LIPTRUZET Approved by the FDA
Merck, known as MSD outside the United States and Canada, today announced that the US FDA has approved LIPTRUZET™(ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.
Nestlé USA Recalls Select California Pizza Kitchen and DiGiorno Frozen Pizzas
Nestlé USA’s Pizza Division today announced the voluntary recall of select production codes of four different frozen pizzas sold in the US.
Trametinib US PDUFA Date Extended to September 2013
GSK today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for trametinib, its MEK inhibitor, has been extended by 3 months to 3 September 2013.
FDA Grants Janssen Research & Development Breakthrough Therapy Designation for Daratumumab
Janssen Research & Development, LLC (Janssen) announced the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD.
Michigan Mom Writes Book on Spina Bifida to Help Others with Disorder
Laurel Greshel felt she had a pretty normal pregnancy in 1983 when she and her husband Ted, were anxiously awaiting the birth of their firstborn daughter, Amanda.