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Eli Lilly and Biogen Wednesday reported back-to-back positive clinical trial results for their investigational Alzheimer’s disease drugs, heating up the race for an effective cure. Read More
Drugmakers developing treatments for diabetic and idiopathic gastroparesis should study those patient populations in separate trials, the FDA says. Read More
The FDA’s crackdown on compounding pharmacies that lack sterile processing controls continued with warning letters to facilities in Florida and Arkansas — bringing to 18 the number of compounders cited this year. Read More
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