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“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
A key committee is urging European regulators to turn down a sickle cell treatment—two years after their American counterparts approved the drug. Read More
The price tag for Novartis’ newly approved and seemingly miraculous gene therapy for a rare childhood disease presents a whole new challenge of its own. Read More