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Cenobamate

[L10653] Cenobamate was granted FDA approval on 21 November 2019.[L10653] … Cenobamate, or YKP-3089, is an antiepileptic drug developed by SK Pharmaceuticals and used to treat partial onset seizures.

Aztreonam

A monocyclic beta-lactam antibiotic originally isolated from Chromobacterium violaceum. It is resistant to beta-lactamases and is used in gram-negative infections, especially of the meninges, bladder, and kidneys. It may cause a superinf...

Chromic nitrate

Plasma protein fraction (human)

[A32512] It is already reviewed under the category of biologics by the FDA where the processing, required tests, requirements and labeling are incorporated.

Delandistrogene moxeparvovec

It was granted accelerated approval by the FDA on June 22, 2023, as the first gene therapy to treat Duchenne Muscular Dystrophy (DMD). … Delandistrogene moxeparvovec is an adeno-associated virus vector-based gene therapy developed by Sarepta Therapeutics.

Gallium Ga-68 gozetotide

[L27006] On December 1, 2020, Ga-68 PSMA-11 was approved by the FDA as the first molecular-targeted drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) … [A225396] Ga-68 PSMA-11 is an imaging agent that binds PSMA during positron emission tomography: it emits positrons to indicate the presence of PSMA-positive prostate cancer lesions in patients with suspected

Amibegron

Amibegron is an agonist for atypical beta3-adrenoceptors which inhibits intestinal motility.

Olaparib

[L41100, L40908, L43792] It was first approved by the FDA and EU in December 2014,[A246020] and by Health Canada in April 2016.[L42820]

Modified vaccinia ankara

Modified Vaccinia Ankara (MVA) refers to an attenuated strain of the Vaccinia virus.

Ibrexafungerp

[A235414,L34349] Ibrexafungerp was granted FDA approval on 1 June 2021.[L34349] … [A235384] Ibrexafungerp is orally bioavailable compared to the echinocandins [caspofungin], [micafungin], and [anidulafungin]; which can only be administered parenterally.