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FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more

Pharmacyclics Receives FDA Approval for Imbruvica in Treatment for Chronic Graft Versus Host Disease

On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC. Imbruvica® is the...more

Genentech and Roche Secure FDA Approval of Multiple Sclerosis Drug Ocrevus

On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved the use of Ocrevus (ocrelizumab) in treating multiple sclerosis (MS). Ocrevus is a new biologic and is the first drug approved by the FDA to treat...more

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