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Pixantrone

Based on this uncertainty, in 2009, the FDA ultimately rejected Cell Therapeutic's initial application for accelerated approval for pixantrone use in relapsed or refractory NHL. … It is currently being tested in Phase III trials. [2] Although pixantrone has not yet received FDA approval in the United States, it has been granted conditional marketing approval by the European Union

Emricasan

Emricasan is the first caspase inhibitor tested in human which has received orphan drug status by FDA.

Tifuvirtide

It has received fast-track designation from the FDA and is in Phase I/II clinical testing.

Rozanolixizumab

[L47122] It was granted orphan drug designation by the FDA in 2019, by the European Medicines Agency (EMA) in April 2020, and by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in November … [L47122] In June 2023, Rozanolixizumab-noli was approved by the FDA under Priority Review for the treatment of adult patients with generalized myasthenia gravis who are positive for the anti-acetylcholine

Melarsomine

It is the only FDA-approved treatment for adult heartworm infection in dogs, however, is is not approved for use in dogs with late-stage infection.

SBT-100

It was granted orphan drug designation by the FDA for the treatment of pancreatic cancer and osteosarcoma.[L44131,L44136]

Etanercept

It is used to treat or manage a variety of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis (AS), and juvenile idiopathic poly-articular arthritis (JIA). … Dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1.

Sodium ascorbate

Octreotide

On June 26, 2020, the first approved delayed-release oral somatostatin analog, Mycapssa, received FDA approval for the long term maintenance treatment of acromegaly.

Clorazepic acid

In September 2020, a black box warning describing these risks was included on the product label of benzodiazepines as per FDA regulation. … Similar to other benzodiazepines, the active metabolite of clorazepate enhances the binding of gamma-aminobutyric acid (GABA) to the GABA type A (GABA-A) receptor, which promotes channel opening and neuronal