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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
The FDA investigators also found inadequate cleaning at the facility that created risks of cross-contamination and inconsistent drug products. Read More
Under the consent decree, the company won’t be able to resume business until it puts together a comprehensive quality control system and is cleared by the FDA. Read More