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Azficel-T

Azficel-T is an autologous cellular product composed of fibroblasts indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. … Intradermal administration of autologous dermal fibroblasts into irradiated skin following surgical procedures was associated with an improved healing process of subsequent surgical wounds [A31927].

Icatibant

It is resistant to bradykinin-cleaving enzyme degradation and has a potency of 2-3 times higher than earlier B₂ receptors antagonists, thus representing a new class of medication. … [A4017,A263046] Icatibant was approved by the FDA on August 25, 2011, and by the EMA in 2008 as a treatment for hereditary angioedema.

rdESAT-6

rdESAT-6 is a recombinant dimer of _Mycobacterium tuberculosis_ early secretory antigenic target used as an ingredient in the diagnostic agent SIILTIBCY along with [rCFP-10].[L53638]

Benznidazole

Benznidazole was granted accelerated approval for the treatment of Chagas disease in children 2-12 years of age by the FDA on August 29, 2017.

Amifostine

A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.

Alirocumab

It is a human monoclonal antibody part of the family of the PCSK9 inhibitors which are a novel class of anticholesterol therapeutics. From this family, it was the first agent to receive FDA approval. … The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety. PCSK9 inhibition facilitates more LDL-C clearance from the blood.

Mecasermin rinfabate

The binding of IGF-1 to IGFBP-3 is said to extend the half life and reduce the clearance of IGF-1 in patients with growth hormone resistant syndromes and low levels of IGFBP-3 though this may represent … Mecasermin rinfabate is approved for severe primary insulin-like growth factor (IGF) deficiency or in patients with GH gene deletion who have developed antibodies to growth hormone (GH)[A176020].

Adalimumab

[L44953] Adalimumab-adaz was approved by the FDA on October 31, 2018. … A high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), a biosimilar to Humira®, was approved by the FDA in May 2024 for the treatment of multiple chronic inflammatory diseases.

Human varicella-zoster immune globulin

Human varicella-zoster immune globulin is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). … lack evidence of immunity to varicella and for whom varicella vaccine is contraindicated.

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