Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.
The U.S. Food and Drug Administration extended the Prescription Drug User Fee Act date for Merck’s supplemental Biologics License Application (sBLA) for Vaxneuvance, a pneumococcal conjugate vaccine intended for preventative use in infants and children.
Gilead Company Kite submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The U.S. Food and Drug Administration approved Pfizer Inc.’s supplemental Biologics License Application for Panzyga to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP).
AstraZeneca and Daiichi Sankyo’s Enhertu received supplemental Biologics License Application (sBLA) acceptance and U.S. priority review for the treatment of HER2-positive metastatic gastric cancer.
August is a busy month on the U.S. Food and Drug Administration)’s calendar, including a target action date for Bristol Myers Squibb’s supplemental Biologics License Application for Opdivo (nivolumab) plus Yervoy (ipilimumab), dosed concomitantly with a limited course of chemotherapy, for the first-line treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
The U.S. Food and Drug Administration extended by three months the regulatory agency’s review of the supplemental Biologics License Application for Arzerra (ofatumumab) as a treatment for patients with relapsing multiple sclerosis.
The U.S. Food and Drug Administration approved a supplemental Biologics License Application for Eli Lilly and Company’s Taltz (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation.