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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
The numbers provided are meant to help the public better understand what the center does, but “observed increases and decreases in these measures should not be seen as improvements or deficiencies,” CDER said. Read More
The FDA issued a warning letter to a Montana compounding pharmacy for insanitary conditions and significant violations of good manufacturing practices. Read More