Drug Target Review

SEPTEMBER 19, 2023

In spite of current success and possibility to be a successful cell technology model, the integration of organ-on-chips into drug development process needs more optimisation to be validated for FDA approval. Nature Cancer. 2022;3(4):418-36. Passini E, Britton OJ, Lu HR, Rohrbacher J, Hermans AN, Gallacher DJ, et al.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

New Drug Approvals

APRIL 22, 2025

R*)))- FDA APPROVED sulopenem etzadroxil, probenecid, 10/25/2024, To treat uncomplicated urinary tract infections (uUTI) Drug Trial Snapshot Sulopenem ( CP-70,429 ) is a thiopenem antibiotic derivative from the penem family, which unlike most related drugs is orally active. . 10 (4): 18151835. PMC 8572892.

FDA Approval 62

FDA Approval FDA Treatment Clinical Trials 62

New Drug Approvals

MAY 20, 2025

Retrieved 15 February 2024. ^ “Bausch + Lomb and Novaliq Announce FDA Approval of Miebo (Perfluorohexyloctane Ophthalmic Solution) for the Treatment of the Signs and Symptoms of Dry Eye Disease” (Press release). Bausch + Lomb Corporation. 18 May 2023.

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FDA Approval FDA Disease Treatment 62

New Drug Approvals

MAY 30, 2025

1] It was approved for medical use in the United States in July 2023. [1] 1] [7] [8] [9] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [10] Food and Drug Administration (FDA). Retrieved 5 August 2023. ^ “Xdemvy: FDA-Approved Drugs” U.S.

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FDA Approval FDA Production International 70

New Drug Approvals

APRIL 13, 2025

Olezarsen FDA APPROVED 12/19/2024, Tryngolza , To treat familial chylomicronemia syndrome Drug Trials Snapshot Synonyms AKCEA-APOCIII-LRX ALL-P-AMBO-5′-O-(((6-(5-((TRIS(3-(6-(2-ACETAMIDO-2-DEOXY-.BETA.-D-GALACTOPYRANOSYLOXY)HEXYLAMINO)-3-OXOPROPOXYMETHYL))METHYL)AMINO-5-OXOPENTANAMIDO)HEXYL))PHOSPHO)-2′-O-(2-METHOXYETHYL)-P-THIOADENYLYL-(3′-O->5′-O)-2′-O-(2-METHOXYETHYL)-P-THIOGUANYLYL-(3

FDA 62

FDA FDA Approval DNA Pharmaceuticals 62

New Drug Approvals

APRIL 27, 2025

octane-8,1′-azolidin-1-ium]-3-yl 2-hydroxy-2,2-diphenylacetate;chloride FDA 2024, Cobenfy 9/26/2024, To treat schizophrenia Press Release Drug Trials Snapshot Trospium chloride is a muscarinic antagonist used to treat overactive bladder. [3] 13 August 2007. ^ “ANDA 091289 approval letter” (PDF).

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FDA Approval FDA Pharmacokinetics Licensing 57

New Drug Approvals

MAY 14, 2025

5] Rezafungin was approved for medical use in the United States in March 2023, [1] [6] [5] and in the European Union in December 2023. [2] 2] It is an echinocandin antifungal [1] [4] that acts as a fungal -glucan synthase inhibitor. [5] 2] [3] CAS No. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0139021. doi: 10.1128/AAC.01390-21.

Pharmacokinetics 62

Pharmacokinetics FDA FDA Approval Treatment 62

New Drug Approvals

MAY 23, 2025

REF [link] References ^ Jump up to: a b “FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria” U.S. Food and Drug Administration (Press release). Durlobactam CAS 1467829-71-5 WeightAverage: 277.25 24 May 2023. Retrieved 24 May 2023.

FDA 62

FDA FDA Approval Hospitals Packaging 62

New Drug Approvals

MAY 26, 2025

1] Flotufolastat ( 18 F) was approved for medical use in the United States in May 2023. [1] FDA Approves Blue Earth Diagnostics’ Posluma (Flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer” (Press release). 18F-rhPSMA-7.3 1] [2] SYNTHESIS Bejot, R., 2 June 2023.

Clinical Trials 62

Clinical Trials FDA FDA Approval Trials 62

New Drug Approvals

MAY 11, 2025

5] Omaveloxolone was approved for medical use in the United States in February 2023, [2] [5] [6] [7] [8] and in the European Union in February 2024. [3] 3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] Food and Drug Administration (FDA). 2] [5] It is taken by mouth.

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FDA FDA Approval Disease Production 57

Drug Target Review

APRIL 25, 2025

Addressing the gaps associated with liver-on-chips, a recent 3D hepatic spheroid study predicted DILI liabilities of 152 FDA-approved small molecules using a high-throughput 384 well plate-based system with a sensitivity of 72 percent and specificity of 89 percent. link] [19] Safarzadeh M, Richardson LS, Kammala AK, et al.

Clinical Development 52

Clinical Development Small Molecule Drugs FDA Approval 52

New Drug Approvals

MAY 22, 2025

This drug is given in combination with -lactam antibiotics to inhibit -lactamase , an enzyme produced by bacteria that destroys the antibiotics. [1] 1] It was patented in 1977 and approved for medical use in 1986. [2] Food and Drug Administration (Press release). National Library of Medicine. 29 March 2023. 24 May 2023.

Pharmacokinetics 62

Pharmacokinetics FDA Production FDA Approval 62

New Drug Approvals

APRIL 23, 2025

Probenecid 57-66-9 4-(Dipropylsulfamoyl)benzoic acid Probenecid acid Benemid 4-(dipropylsulfamoyl)benzoic acid C 13 H 19 NO 4 S, 285.359 HC 5006 NSC-18786 FDA APPROVED, 10/25/2024, sulopenem etzadroxil, probenecid, Orlynvah , To treat uncomplicated urinary tract infections (uUTI) Drug Trial Snapshot Probenecid , also sold under the brand name Probalan (..)

Pharmacokinetics 62

Pharmacokinetics FDA Production Regulations 62

New Drug Approvals

APRIL 21, 2025

Jump up to: a b c d e f g h i j k “FDA approves drug for heart disorder caused by transthyretin-mediated” U.S. Food and Drug Administration. Jump up to: a b “Novel Drug Approvals for 2024” U.S. Jump up to: a b “Novel Drug Approvals for 2024” U.S. PMC 6276790.

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