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.
The U.S. Food and Drug Administration approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1%).
The U.S. Food and Drug Administration approved FoundationOne Liquid CDx, a new pan-tumor liquid biopsy test that is indicated for use as a companion diagnostic for four FDA-approved precision therapies.
Following approval of the world’s first approved coronavirus vaccine, Russia plans to initiate a new study involving 40,000 people as the country looks to boost production and distribute ‘Sputnik V’ to patients in that country and others it has struck deals with.
The U.S. Food and Drug Administration approved the expansion of Amgen’s Kyprolis (carfilzomib) U.S. prescribing information to include the product’s use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens – once weekly and twice weekly – for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.
The U.S. Food and Drug Administration approved Novartis’ Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis in adults.
The U.S. Food and Drug Administration approved Roche’s Enspryng for the central nervous system disorder neuromyelitis optica, putting the Swiss drugmaker head-to-head with Alexion’s Soliris in a costly treatment area.
The U.S. Food and Drug Administration granted accelerated approval for NS Pharma’s Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy.
Scientists from across the globe expressed concern over the lack of available data that could provide a key to how well the world’s first Covid-19 vaccine – approved in Russia without going through Phase III testing – could work stemming the rise of the novel coronavirus.
The U.S. Food and Drug Administration approved Trevena’s Olinvyk as a new intravenous opioid for short-term management of acute pain in a hospital setting.
