The U.S. Food and Drug Administration accepted Copenhagen, Denmark-based Orphazyme’s New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick disease Type C.
The U.S. Food and Drug Administration approved Athena Bioscience LLC’s Qdolo (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
A look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.
Shares of Reata Pharmaceuticals plunged more than 33 percent after the company announced a potential delay in plans to seek approval of omaveloxolone, an investigational treatment of Friedreich’s ataxia (FA).
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.