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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
Four Republican senators are urging Acting FDA Commissioner Ned Sharpless to expand the agency’s Parallel Track program to give patients with incurable diseases a chance at recovery. Read More
The World Health Organization on Tuesday adopted a drug price transparency resolution that critics have already lambasted as a sop to big pharma. Read More
Opening statements began on Tuesday in Oklahoma’s trial against Johnson & Johnson for the company’s alleged role in the opioid crisis—just two days after the state’s Attorney General Mike Hunter announced a settlement agreement with the other remaining defendant, Teva Pharmaceuticals, for $85 million. Read More
Requirements for acquiring written confirmations for importing active substances into the UK from EU and third countries won’t change—and UK drugmakers will still need to obtain them from the relevant issuing authorities in those countries. Read More