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FDA granted accelerated approval to Amgen’s Blincyto (blinatumomab) for the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Read More
Amgen will move omecamtiv mecarbil, for the treatment of chronic heart failure, into Phase III development in collaboration with Cytokinetics. Read More
Presidential hopeful Hillary Clinton has unveiled a plan to rein in exorbitant drug costs for lifesaving treatments that would penalize drugmakers for price-gouging. Read More
The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
Nearly two years after the agency said that it would review its regulatory framework on off-label use, the FDA announced that it would hold a meeting Nov. 9 and 10 to involve stakeholders in the framing of guidance and regulations on unapproved uses. Read More