The US Food and Drug Administration has issued its first approval for a drug to treat lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach and other abdominal areas.
Schering-Plough Europe has withdrawn its European marketing authorisation application for the proposed asthma treatment, Zenhale (mometasone furoate/formoterol fumarate), the European Medicines Agency announced.
The US Food and Drug Administration has approved Kombiglyze, a new Type 2 diabetes drug that combines saxagliptin and metformin XR in a single tablet, according to the drug’s sponsors, AstraZeneca Plc and Bristol-Myers Squibb Co.
The US Food and Drug Administration has approved a new indication for Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.
The US Food and Drug Administration has issued a ‘complete response letter’ to Biodel Inc of Danbury, Connecticut rejecting its new drug application for Linjeta, a rapid-acting injectable regular human insulin for Types 1 and 2 diabetes.
The US Food and Drug Administration has approved the Novartis cancer drug, Afinitor (everolimus), for a new indication which is to treat patients with a benign brain tumour but who are not candidates for surgery.
The US Food and Drug Administration has approved a new indication for the cancer drug, Sprycel (dasatinib), enabling it to be administered to patients with a rare blood cancer when it is first diagnosed.
Elan Plc said that it has developed an assay that appears to identify those multiple sclerosis patients on Tysabri (natalizumab) who are at risk of developing the rare brain disease, progressive multifocal leukoencephalopathy (PML).
The UK government has launched two new life science clusters that will bring experts from industry, the academic community and the National Health Service together to do early-stage drug development.
AstraZeneca Plc’s new nasal spray vaccine designed to prevent seasonal flu has been given a positive opinion by the European Medicine Agency’s main scientific committee, the Committee for Medicinal Products for Human Use.