The U.S. Food and Drug Administration accepted the filing of Aurinia Pharmaceuticals Inc.’s New Drug Application (NDA) for voclosporin as a potential treatment for lupus nephritis, a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
The U.S. Food and Drug Administration accepted Acadia Pharmaceuticals Inc.’s application for an antipsychotic drug to treat dementia patients with hallucinations and delusions.
U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
South San Francisco-based Akero Therapeutics presented results from a 16-week analysis of secondary and exploratory endpoints in the company’s Phase IIa BALANCED clinical trial of efruxifermin in nonalcoholic steatohepatitis (NASH).
Myovant announced topline results from SPIRIT 1, the second Phase III trial of once-daily relugolix combination therapy in women with pain linked with endometriosis.
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.
A look at the U.S. Food and Drug Administration’s drug approval review calendar.
The U.S. Food and Drug Administration approved Incyte’s Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test.
The U.S. Food and Drug Administration accepted a New Drug Application and two supplemental NDAs for Genentech’s Xofluza (baloxavir marboxil).