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The European Commission has approved Bristol-Myers Squibb’s PD-1 inhibitor Nivolumab BMS for the treatment of advanced or metastatic squamous non-small cell lung cancer, the second indication approved for the drug in a month. Read More
Biosimilars makers must have FDA approval of their product before giving the reference product manufacturer 180-day notice of first commercial marketing, the Federal Circuit Court of Appeals ruled Tuesday — in a decision that bars Sandoz from marketing its Neupogen biosimilar until Sept. 2. Read More
Bristol-Myers Squibb has received breakthrough therapy designation from the FDA for its first-in-class investigational BMS-663068 compound for use in preventing HIV infection. Read More
The FDA continues to crack down on generic drugmakers that owe GDUFA fees, hitting Indian drugmaker Vista Pharmaceuticals with a warning letter for failing to pay fees for the last three fiscal years. Read More
Exelixis’ Cometriq improved patient outcomes in a pivotal Phase 3 trial for metastatic kidney cancer — signaling new life for the drug, which failed another study last fall. Read More
Regulators in the EU have cleared the way for Amgen to market its cholesterol-lowering drug Repatha, marking the world’s first approval of a PCSK9 inhibitor. Read More
Two institutional buyers of Gleevec want to stop its manufacturer, Novartis, from delaying generic competition of the blockbuster leukemia drug, saying a patent litigation settlement between the brandmaker and generics maker Sun Pharma was construed solely for that purpose. Read More