The FDA’s Safer Technologies Program, or STeP, is part of an overarching emphasis on safety, and the related draft guidance focuses largely on the process of applying for a STeP device. However, a member of the FDA staff said on a webinar that device accessories – and devices that make other devices safer – are also eligible for the program.

BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance. Beigene said Brukinsa is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells. It is also the only BTK inhibitor that can be taken once or twice daily. Brukinsa is expected to be launched in the U.S. in the coming weeks.

The U.S. FDA has given its final approval to Coopervision Inc.'s Misight 1 day, the first contact lens designed to slow the progression of myopia, or near-sightedness, in children. The single use, disposable, soft contact lens is indicated for children who are diagnosed with myopia and begin Misight treatment at an early age. Specifically, the FDA indication said that "Misight (omafilcon A) daily wear single use soft contact lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal."