The U.S. Food and Drug Administration and Health Canada approved Inqovi (decitabine and cedazuridine) tablets as the first orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS).
The U.S. Food and Drug Administration granted approval of Endo International’s Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. QWO is the first FDA-approved injectable treatment for cellulite.
The U.S. Food and Drug Administration approved GlaxoSmithKline Plc’s HIV drug Rukobia to treat adult patients who have run out of treatment options.
The U.S. Food and Drug Administration approved ViiV Healthcare’s Rukobia (fostemsavir) as a first-in-class treatment for HIV in adults with few treatment options available.
The U.S. Food and Drug Administration approved Bavencio (avelumab) for maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-containing chemotherapy.
Treatments for peanut allergy and Parkinson’s disease are among U.S. drug launches that have been postponed by the COVID-19 pandemic as drugmakers struggle with disruptions to business, a Reuters review of filings and interviews with executives show.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
The U.S. Food and Drug Administration approved Zogenix Inc.’s Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
