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The European Medicines Agency has recommended approval of Shire’s Intuniv to treat attention deficit hyperactivity disorder — potentially breathing new life into the drug, which is facing new competition from generics in the U.S. 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
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
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
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More