March 14, 2016
USPTO issues Notice of Allowance to Horizon Pharma for VIMOVO
United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance to Horizon Pharma for U.S. patent application number…
Pharmaceuticals, Biotechnology and Life Sciences
Category: Approval
February 19, 2016
AstraZeneca’s Brilique OK for marketing in EU
The European Commission has granted to AstraZeneca marketing authorisation for Brilique (ticagrelor) at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event.
February 17, 2016
Durvalumab granted BTD by FDA for cancer patients
AstraZeneca and MedImmune, its global biologics research and development arm, on Wednesday announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen.
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 29, 2015
Sanofi’s vaccines division gets Dengvaxia approval in Brazil
Sanofi Pasteur, the vaccines division of Sanofi, has gotten from Brayil regulatory approval to Dengvaxia. As the company said Monday ,…
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.
December 22, 2015
FDA approves India’s Aurobindo’s generic version of Alcon’s Patanol
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% which makes the product is ready for launch.
December 17, 2015
Lilly’s and Boehringer Ingelheim’s insuline injection gets FDA’s nod
Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) were granted approval by the U.S. Food and Drug Administration (FDA) for Basaglar (insulin glargine injection) 100 units/mL.
December 15, 2015
Allergan’s IBS-D treatment Viberzi can be now prescribed in U.S.
Allergan has announced today that its first-in-class treatment for irritable bowel syndrome with diarrhea (IBS-D) – Viberzi – is now available by prescription in the U.S.
December 9, 2015
FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients
The U.S. Food and Drug Administration has approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.