November Could See US FDA Action On Five Breakthrough Applications, Nine Novel Agents
BioMarin’s Voxzogo, J&J’s cilta-cel and Takeda’s maribavir are among the novel agents with goal dates on US FDA’s November user fee calendar.
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Janssen says the review at the European Medicines Agency of its marketing authorization application for cilta-cel reverted to standard timelines because the EMA wanted a GMP inspection and provision of a GMP certificate, "which did not allow continuation of the accelerated assessment timetable.”
Takeda’s Maribavir Post-Transplant CMV Indication Should Not Be Limited By Resistance, US Panel Says
Advisory committee unanimously endorses novel antiviral for treatment of post-transplant patients with refractory/resistant cytomegalovirus infection, and in the process rejects US FDA’s proposal to distinguish target population based upon genetic resistance.
Janssen’s Mark Wildgust explained how the Johnson & Johnson subsidiary is pushing forward with novel therapeutics and combination regimens with the goal of eliminating myeloma in the first line.