US FDA Approves Janssen’s IMBRUVICA to Treat Chronic Graft-Versus-Host Disease

The US Food and Drug Administration (FDA) of the United States has approved Janssen Pharmaceutical’s IMBRUVICA for the treatment of pediatric patients one year and older suffering with chronic graft-versus-host disease after the failure of more than one therapy. Janssen claims that, this milestone marks the first pediatric indication for IMBRUVICA, and the launch of […]

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North Carolina Facility of Glenmark Pharma Gets US FDA OAI Status

Glenmark Pharmaceuticals Limited has announced that the company has received Official Action Indicated (OAI) status from the US Food and Drug Administration (USFDA) for the Monroe, North Carolina (USA) facility. The OAI classification implies the inter-alia that the US FDA might withhold the approval of any pending product applications, and the supplements filed from the […]

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