The FDA has accepted the NDA for reproxalap for the treatment of dry eye disease.
The approval was based on data from previous studies that included 124 adolescent patients, as well as the phase 3 JADE TEEN study.
The conversion to regular approval was based on data from an additional 141 patients with dMMR recurrent or advanced endometrial cancer who had progressed on or after a platinum-containing regimen.
The study analyzed 29,278 women who were in labor at 28 weeks’ gestation or more and who were planning a vaginal delivery.
Nyxol is a once-daily, preservative-free eye drop formulation of phentolamine mesylate.
Tascenso ODT is a sphingosine 1-phosphate receptor modulator.
Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor.
Rebyota is a fecal microbiota suspension for rectal administration.
Skyclarys activates the Nrf2 pathway which is involved in the cellular response to oxidative stress.
The approval was based on data from a phase 3 study which included adults with steroid-resistant active PMR who flared on at least 7.5mg per day of prednisone or equivalent during taper.
