October 19, 2016
FDA approves Roche’s cancer immunotherapy Tecentriq for metastatic NSCLC
FDA approves Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) for people with a specific type of metastatic lung cancer.
Pharmaceuticals, Biotechnology and Life Sciences
Tag: FDA
October 11, 2016
FDA’s approval of NIcox’s cetirizine eye drop formulation triggers $35M in NIcox shares
The approval of the AC-170 NDA after December 1, 2016 would trigger a milestone payment of $10 million in Nicox shares to ex-Aciex shareholders or $35 million in Nicox shares if approval of the NDA is received before this date.
October 10, 2016
Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170
Nicox S.A. the international ophthalmic R&D company, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis.
September 9, 2016
First Dechra’s FDA approval for US generic entrant antibiotic
Dechra, an international specialist veterinary pharmaceuticals company, has received approval from the U.S. Food and Drug Administration (FDA) for a generic antibiotic.
April 8, 2016
Biosimilars: More Treatment Options Are on the Way
As the medical market grows, the US Food and Drug Administration FDA has published a neat piece about biosimilars. Recently, FDA has approved a second biosimilar product—Inflectra (Infliximab-dyyb), a biosimilar to Remicade (infliximab)—and expects to approve other biosimilars in the future.
March 16, 2016
FDA warns public about eye drop bottles with loose safety seals
FDA warns public about eye drop bottles with loose safety seals
February 22, 2016
FDA Accepts Sanofi NDA for Combination of Insulin Glargine and Lixisenatide (diabetes)
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Sanofi’s investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
January 6, 2016
LivaNova: “FDA’s Warning Letter can be resolved without material impact on financial results”
LivaNova said that FDA’s Warning Letter can be resolved without a material impact on financial results.
January 6, 2016
Glenmark’s generic Multaq tablets wait for final FDA approval after tentative
Glenmark Pharmaceuticals Inc., has been granted tentative approval by the USFDA for its Dronedarone Tablets, 400 mg, the generic version…
December 22, 2015
Glenmark’s Linezolid, version of Pfizer’s Zyvox, gets nod from FDA
Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Linezolid Tablets, 600 mg, the therapeutic equivalent of Zyvox Tablets, 600 mg of Pharmacia and Upjohn Company, a subsidiary of Pfizer, Inc.