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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
Amgen is seeking approval for its 420 mg monthly dosage form of Repatha just over two weeks after the FDA signed off on the PCSK9 inhibitor to control low-density lipoprotein cholesterol. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More