Blog
RSS FeedPosted by Michael Wonder on 05 Aug 2015
FDA approves Avastin for ovarian cancer
Roche has garnered a new indication for Avastin from US regulators, this time in combination with chemotherapy for the treatment ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb and AbbVie Receive U.S. FDA breakthrough therapy designation for elotuzumab, an investigational humanized monoclonal antibody for multiple myeloma
Bristol-Myers Squibb Company and AbbVie today announced that the U.S. Food and Drug Administration (FDA) has granted elotuzumab, an investigational humanized monoclonal ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Ofev to treat idiopathic pulmonary fibrosis
The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF). ...
Posted by Michael Wonder on 05 Aug 2015
Novartis gains FDA approval for Signifor LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder
Novartis announced today that the US Food and Drug Administration (FDA) has approved Signifor long-acting release (LAR) (pasireotide) for injectable suspension, for ...
Posted by Michael Wonder on 05 Aug 2015
Pozen’s Yosprala receives complete response letter from the FDA
Pozen Inc, a pharmaceutical company committed to transforming medicine that transforms lives, announced today that their investigational drug candidates Yosprala 81/40 and 325/40 ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first biosimilar product Zarxio
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first generic versions of celecoxib
The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid ...
Posted by Michael Wonder on 05 Aug 2015
US FDA accepts for review a biologics license application for Merck and Sanofi Pasteur’s investigational paediatric hexavalent vaccine
Merck, known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi, announced today ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves additional antibacterial treatment for plague
The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Lymphoseek to help determine the extent of head and neck cancer in the body
The U.S. Food and Drug Administration today approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic ...
Posted by Michael Wonder on 05 Aug 2015
Janssen files four-times-a-year schizophrenia shot
Johnson & Johnson group Janssen has filed an application in the US to market a three-month injectable formulation of paliperidone palmitate for ...
Posted by Michael Wonder on 05 Aug 2015
Galderma receives FDA approval of novel treatment option for rosacea patients
Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration approved Soolantra (ivermectin) cream, 1% for the once-daily topical treatment ...
Posted by Michael Wonder on 05 Aug 2015
Novartis' new heart failure medicine LCZ696, now called Entresto, approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization
Novartis announced today that the US Food and Drug Administration (FDA) has approved Entresto (sacubitril/valsartan) tablets, previously known as LCZ696, for ...
Posted by Michael Wonder on 05 Aug 2015
Novartis combination therapy Tafinlar and Mekinist achieves important EU and US regulatory milestones
Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has ...
Posted by Michael Wonder on 05 Aug 2015
First vaccine approved by FDA to prevent serogroup B Meningococcal disease
The U.S. Food and Drug Administration announced today the approval of Trumenba, the first vaccine licensed in the United States ...