THURSDAY, Oct. 15, 2020 -- The first drug for Zaire ebolavirus (Ebola virus) infection has been approved for adults and children, the U.S. Food and Drug Administration announced Wednesday.
Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) is a mixture of three monoclonal antibodies that simultaneously block entry of the virus. The approval also applies to newborns of mothers who have tested positive for Ebola virus.
MONDAY, Oct. 5, 2020 -- On Friday, the U.S. Food and Drug Administration announced the approval of a drug combination for first-line treatment of unresectable malignant pleural mesothelioma (MPM) -- the first drug regimen to be approved for mesothelioma in 16 years.
The combined regimen of Opdivo (nivolumab) 360 mg every three weeks and Yervoy (ipilimumab) 1 mg/kg ever six weeks is now the second approved treatment for adults with MPM. According to the FDA, the combination of these monoclonal antibodies has been shown to decrease tumor growth by enhancing T-cell function.
THURSDAY, Aug. 27, 2020 -- The first rapid COVID-19 test that does not need any special computer equipment to produce results was approved by the U.S. Food and Drug Administration on Wednesday.
Made by Abbott Laboratories, the 15-minute test will sell for $5, giving it an edge over similar tests that need to be inserted into a small machine, the Associated Press reported. No larger than a credit card, the Abbott test is based on the same technology used to test for the flu, strep throat, and other infections. BinaxNOW is the fourth rapid test in the United States that detects COVID-19 antigens rather than the virus itself. It is considered a faster, but less precise, screening method.
THURSDAY, Aug. 13, 2020 -- Accelerated approval has been granted to Viltepso (viltolarsen) injection for treatment of patients with Duchenne muscular dystrophy (DMD) and a mutation of the DMD gene amenable to exon 53 skipping, the U.S. Food and Drug Administration announced Wednesday.
About 8 percent of DMD patients have a mutation amenable to exon 53 skipping, the FDA notes. Viltepso is administered by a health care professional at a dose of 80 mg/kg in 60-minute weekly intravenous infusions at home, a hospital, or a treatment center.
MONDAY, Aug. 10, 2020 -- The opioid Olinvyk (oliceridine) was granted approval for the management of moderate-to-severe acute pain in controlled settings, the U.S. Food and Drug Administration announced Friday.
Olinvyk is indicated for short-term intravenous use in adults with pain that is severe enough to require an intravenous opioid and who are inadequately treated with other alternatives. The drug is approved only for use in hospitals or other controlled settings and is not for at-home use. The maximum recommended daily dose is 27 mg.
MONDAY, July 27, 2020 -- Tecartus (brexucabtagene autoleucel) received approval for the treatment of mantle cell lymphoma (MCL) in patients who have not responded to other treatment types or relapsed following treatment, the U.S. Food and Drug Administration announced Friday.
Tecartus is a chimeric antigen receptor (CAR) T cell therapy and the first cell-based gene therapy approved for the treatment of MCL. Each dose of the drug is customized based on a patient's immune system.
WEDNESDAY, July 8, 2020 -- The U.S. Food and Drug Administration has approved Inqovi (decitabine and cedazuridine) tablets, an oral outpatient treatment option for patients with myelodysplastic syndromes and chronic myelomonocytic leukemia, the agency announced Tuesday.
Inqovi provides another option for patients who previously needed intravenous therapy and will reduce the need for them to frequently visit health care facilities. The tablet is taken once daily for five consecutive days in a 28-day cycle.