Abbott received U.S. Food and Drug Administration Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of the company’s BinaxNOW COVID-19 Ag Self Test for detection of COVID-19 infection.
The U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel) as the first anti-BCMA CAR T cell therapy for relapsed or refractory multiple myeloma.
The U.S. Food and Drug Administration approved Kiniksa Pharmaceuticals’ Arcalyst for the treatment of recurrent pericarditis, the first medication cleared for this indication.
Johnson & Johnson will launch the newly approved drug Ponvory for adults with relapsing multiple sclerosis (MS) in the United States during early April 2021 at a similar price point to rival treatments, the company’s Janssen Pharmaceutical unit said on March 19.
The U.S. Food and Drug Administration approved Melinta Therapeutics’ Kimyrsa (oritavancin) for the treatment of adults with acute bacterial skin and skin structure infections caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus.
The U.S. Food and Drug Administration approved Aveo Oncology’s Fotivda (tivozanib) for adults with relapsed or refractory advanced renal cell carcinoma in people who have had two or more previous systemic therapies.
The U.S. Food and Drug Administration approved BridgeBio Pharma and affiliate Origin Biosciences’ injectable, rare genetic metabolic disorder therapy Nulibry (fosdenopterin).
The U.S. Food and Drug Administration approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping.
The U.S. Food and Drug Administration approved AbbVie’s biologic therapy Humira (adalimumab) as a treatment for moderate-to-severe active ulcerative colitis in children aged 5 years and older.
