FDA Approvals Monthly Roundup: August 2020
The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs. Each month, the administration approves numerous new therapeutics. We have summarized the FDA approvals for August below. You can use the hot links to learn more about the drugs.
Tafasitamab (DB15044), a CD19-directed cytolytic monoclonal antibody for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Risdiplam (DB15305), the first orally available therapy for the treatment of spinal muscular atrophy (SMA).
Belantamab mafodotin (DB15719), an monoclonal antibody conjugated to a microtubule disruptor for the treatment of multiple myeloma.
Nifurtimox (DB11820) for the treatment of American Trypanosomiasis in children based on promising results from phase III clinical trials.
Oliceridine (DB14881), a biased opioid agonist for the management of severe acute pain.
Viltolarsen (DB15005), an antisense phosphorodiamidate morpholino oligonucleotide for the treatment of Duchenne muscular dystrophy patients with mutations amenable to exon 53 skipping.
Enspryng (satralizumab-mwge) (DB15762), an interleukin-6 receptor-directed monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in patients who are aquaporin-4 (AQP4) seropositive.
CRYSTADROPS®, a new ophthalmic formulation of Cysteamine (DB00847) for the treatment of corneal cystinosis.
Somapacitan (DB15093) a growth hormone analog to treat adults with growth hormone deficiency.