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The FDA has granted breakthrough therapy designation to Amgen’s bispecific T cell engager (BiTE) antibody blinatumomab for the treatment of a rapidly progressing blood and bone marrow cancer, paving the way for speedy development and review of the drug. Read More
Allergan got bad and good news recently from the FDA, with the agency rejecting for a second time the company's migraine treatment Semprana due to manufacturing issues but approving a new indication for its eye treatment Ozurdex. Read More
Drug approved under the qualified infectious disease products designation, created in 2012 to spur development of drugs for increasingly resistant pathogens. Read More
The FDA on Friday approved Los Angeles-based MannKind Corp.’s rapid-acting inhaled insulin Afrezza Inhalation Powder to control blood sugar levels in adults with common type 2 diabetes during meals. Read More
A key European panel recommended approval for Eli Lilly and Boehringer Ingelheim’s biosimilar of Sanofi’s blockbuster long-acting insulin drug Lantus, creating a potential threat to the French drugmaker’s multi-billion dollar product. Read More
A European Medicines Agency committee has recommended approval of Bristol-Myers Squibb’s direct-acting antiviral Daklinza in combination with other drugs for the treatment of chronic hepatitis C virus (HCV) infection in adults. Read More
Generics maker Ranbaxy has the green light to launch an exclusive version of Novartis’ blockbuster hypertension drug Diovan, a move that comes nearly two years after the drug lost patent protection. Read More