Tag Archives: teva

December, 2018

26 December
FDA Approves First and Only Digital Inhaler with Built-in Sensors – ProAir Digihaler Inhalation Powder

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to …
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11 October
Celltrion and Teva Announce FDA Advisory Committee Recommends Approval of CT-P10, a Proposed Rituximab Biosimilar

SILVER SPRING, Md. & JERUSALEM–(BUSINESS WIRE)– Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan®1 (rituximab) for the treatment of …
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11 October
Teva Presents 25-Year Safety Data from Longest Continuous Trial of Copaxone for Treatment of Relapsing Forms of Multiple Sclerosis

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced safety and tolerability results representing 25 years of data from the open-label extension study of the original U.S. pivotal trial of COPAXONE®(glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (RMS). The extension study initially examined …
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19 September
FDA Approves Teva’s Ajovy Injection for the Prevention and Treatment of Migraine in Adults

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved AJOVYTM (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. AJOVY, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the …
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16 August
Teva and Regeneron Announce Positive Results from Phase 3 Trial of Fasinumab in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip

JERUSALEM & TARRYTOWN, N.Y.–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. At the week 16 primary …
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15 January
FDA Approves Teva’s Trisenox Injection for First-Line Treatment of Acute Promyelocytic Leukemia

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of …
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4 October
FDA Approves Mylan’s Generic Version of Teva’s Multiple Sclerosis Drug Copaxone

HERTFORDSHIRE, England, and PITTSBURGH, Oct. 3, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva’s Copaxone® 40 …
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13 September
FDA Grants Priority Review to Teva’s Trisenox as First-Line Therapy for Low to Intermediate Risk of Acute Promyelocytic Leukemia

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental New Drug Application (sNDA) for the use of TRISENOX® (arsenic trioxide) injection in combination with all-trans retinoic acid (ATRA) for induction of remission and consolidation in patients with …
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31 August
FDA Approves Teva’s Austedo for Treatment of Tardive Dyskinesia in Adults

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO® (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. AUSTEDO® was previously approved for the treatment of chorea associated with Huntington’s disease in April 2017. Tardive dyskinesia is a …
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31 July
FDA to Review Teva and Celltrion’s BLA for Proposed Biosimilar to Herceptin

INCHEON, Republic of Korea & JERUSALEM–(BUSINESS WIRE)–Jul. 31, 2017– Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P6, a proposed Monoclonal Antibody (mAb) biosimilar to Herceptin®1 (INN: trastuzumab) which is used for the treatment of Human Epidermal …
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