An FDA advisory panel voted overwhelmingly against the use of testosterone-replacement drugs for "low-T" Wednesday, saying the label should narrow and that more safety information is needed.
FDA panel votes overwhelmingly against Low-T drugs; Stenda approved for fast-acting ED treatment; and Bayer hones life-sci focus, spins off material sciences business.
A mélange of new treatments awaiting approval and a lack of patient support are driving down drug utilization for Gilead's HCV blockbuster, according to a new study.
Keytruda was the first of the new PD-1 class of immuno-oncology drugs to reach the US, but Bristol-Myers Squibb and Ono could run away with the competition, according to one analyst.
Allergan inches closer to Valeant takeover; Mylan trials underway for Lantus biosimilar and generic Advair; FDA advisers to make decision tomorrow on whether testosterone products are being prescribed correctly and if the drugs' label merits change.
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