ATLANTA, GA — UCB, a global biopharmaceutical company, announced today that ZILBRYSQ® (zilucoplan) is now available in the U.S. for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ZILBRYSQ was approved by the U.S. Food and Drug Administration (FDA) on October 17,...
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EMERYVILLE, Calif. – Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies today announced the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the company’s supplemental New Drug Application (sNDA) for the use of FINTEPLA® for the treatment of seizures associated...
EMERYVILLE, Calif. – Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced new data showing the positive impact of treatment with FINTEPLA® (fenfluramine) oral solution on everyday executive function for children and young adults with Lennox-Gastaut syndrome (LGS). FINTEPLA is being investigated for the treatment of...
EMERYVILLE, Calif. – Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, announced that its product FINTEPLA® (fenfluramine) oral solution has been recognized by two distinguished clinicians in an Epilepsy & Behavior editorial titled “Raising the Bar: Fenfluramine Sets New Treatment Standards for Dravet Syndrome.” In the editorial, the authors, Joseph...
PENNINGTON, N.J. and AHMEDABAD, India — Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., a global innovation led healthcare company, today announced positive topline results from the pivotal EPICS-III Phase 2(b)/3 clinical trial. In this trial, the safety and efficacy of Saroglitazar, an investigational alpha/gamma Peroxisome Proliferator-Activated Receptor (PPAR) agonist, was evaluated for...
VANCOUVER, British Columbia – Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, provided key accomplishments from the past year and announced priorities for 2018. “2017 was a great year for Zymeworks and we are poised to achieve a number of important corporate milestones in 2018,” said Ali Tehrani,...
VANCOUVER, British Columbia — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug...
VANCOUVER, British Columbia — Zymeworks Inc. (Nasdaq: ZYME) a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced positive topline results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera® (zanidatamab-hrii) in combination...
DEVON, Pa. – Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that the European Patent Office has issued Patent No. 3687513, titled “Treatment of Fragile X Syndrome and Autism with Cannabidiol,” which includes claims directed to methods...
DEVON, Pa. – Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a confirmatory Phase 3 trial of Zygel in patients with Fragile X...