FDA Approves Kanuma (sebelipase alfa) for Lysosomal Acid Lipase Deficiency
December 8, 2015 -- Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL)...
View ArticleTeva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of...
JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Dec. 8, 2015-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) today announce that the U.S. Food and...
View ArticleFDA Approves Otiprio (ciprofloxacin otic suspension) for the Treatment of...
SAN DIEGO, Dec. 11, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and...
View ArticleFDA Approves Vistogard (uridine triacetate) for Emergency Treatment for...
December 11, 2015 -- The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer...
View ArticleFDA Approves Alecensa (alectinib) for ALK-Positive Non-Small Cell Lung Cancer
December 11, 2015 -- The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease...
View ArticleFDA Approves Expanded Age Indication for Gardasil 9 in Males
KENILWORTH, N.J.--(BUSINESS WIRE) December 15, 2015 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved an...
View ArticleFDA Approves Bridion (sugammadex) to Reverse Effects of Neuromuscular...
December 15, 2015 -- The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium...
View ArticleFDA Approves Basaglar (insulin glargine) for Type 1 and Type 2 Diabetes
December 16, 2015 -- The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric...
View ArticleFDA Approves Expanded Indication for Keytruda (pembrolizumab) for the...
KENILWORTH, N.J.--(BUSINESS WIRE) December 18, 2015 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved...
View ArticleFDA Approves Zurampic (lesinurad) to Treat High Blood Uric Acid Levels...
December 22, 2015 -- The U.S. Food and Drug Administration today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in...
View ArticleFDA Approves Uptravi (selexipag) for Pulmonary Arterial Hypertension
December 22, 2015 -- On December 21, the U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and...
View ArticleMerz North America Announces FDA Approval of Xeomin (incobotulinumtoxinA) for...
RALEIGH, N.C.- December 23, 2015 --Merz North America, U.S. affiliate of the global Merz Pharma Group, announces that Xeomin (incobotulinumtoxinA) has received U.S. FDA approval for the treatment of...
View ArticleTeikoku Pharma USA, Inc. Announces FDA Approval of Docetaxel Injection,...
San Jose, Calif. - December 28, 2015 - Teikoku Pharma USA (TPU) announced today that the U.S. Food and Drug Administration ("FDA") has approved Docetaxel Injection, Non-Alcohol Formula ("Docetaxel...
View ArticleFDA Approves Expanded Use of GSK Hib Vaccine From Booster Dose To Full Series
Philadelphia, 15 January 2016 -- GSK [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration approved an expanded age indication for Hiberix [Haemophilus b Conjugate Vaccine (Tetanus...
View ArticleNovartis Receives FDA Approval for Cosentyx (secukinumab) to Treat Patients...
EAST HANOVER, N.J., Jan. 15, 2016 Novartis announced today that the US Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for two new indications - the treatment of adult patients...
View ArticleImpax Receives Approval of Emverm (mebendazole) Chewable Tablets
HAYWARD, Calif., Jan. 15, 2016 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the United States Food and Drug Administration (FDA) has approved the Company's supplemental...
View ArticleGenmab Announces U.S. FDA Approval of Arzerra (ofatumumab) as Extended...
Copenhagen, Denmark; January 19, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application...
View ArticleAllergan Announces FDA Approval of Updated Label for New Dosing Regimen for...
DUBLIN, Jan. 21, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's...
View ArticleU.S. Food And Drug Administration Approves Humulin R U-500 KwikPen
INDIANAPOLIS, Jan. 21, 2016 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Humulin R U-500 KwikPen (insulin human injection) 500 units/mL, a pre-filled...
View ArticleFDA Approves New Kyprolis (Carfilzomib) Combination Therapy for the Treatment...
THOUSAND OAKS, Calif., Jan. 21, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of...
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