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Raptor Pharmaceuticals says it does not plan to develop its liver drug, RP103, after it missed the primary endpoint in a Phase 2b study for nonalcoholic steatohepatitis in children. Read More
Sanofi’s LixiLan met the primary endpoint in a pivotal Phase 3 trial showing a greater drop in average blood glucose in diabetes patients when combined with Lantus (insulin glargine). Read More
A joint FDA advisory panel voted unanimously Friday to recommend Collegium Pharmaceutical’s Xtampza ER NDA, deciding that the possible risks related to food effects on the opioid’s efficacy were forgiving and not likely to pose serious safety challenges. Read More
European drugmakers are pressing regulators to streamline the conditional marketing authorization pathway for drugs that fulfill unmet needs, saying the current system is slower than the standard authorization process. Read More
Aridis Pharmaceuticals has received FDA fast track designation for its AR-301, a monoclonal antibody that is under development to treat acute pneumonia caused by certain bacteria, including multidrug-resistant MRSA strains. Read More
Drugmakers submitting an NDA or BLA with a tropical disease priority review voucher will pay a $2.7 million fee in fiscal year 2016 — a $165,000 increase over this year, which ends Sept. 30. Read More