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The agency wants biosimilar sponsors to be ready for the 2019-2020 flu season and is urging sponsors to get their applications in by June 17. Read More
Working out of the firm’s Chevy Chase, Maryland office, Gottlieb will be involved as a full-time active investor across all the firm’s healthcare activities, with a focus on biopharmaceutical and healthcare services. Read More
“Today’s approval marks another milestone in the transformational power of gene and cell therapies to treat a wide range of diseases,” said Acting FDA Commissioner Ned Sharpless. Read More
A lower court’s dismissal of a case involving a patient’s suicide while taking generic versions of GlaxoSmithKline’s antidepressant Paxil (paroxetine) will stand, the Supreme Court has ruled. Read More
The FDA is calling for comments on a potential change to the agency’s REMS for opioid pain meds to require blister packaging for certain immediate-release products. Read More