New Drug Approvals

JUNE 11, 2025

4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] The FDA rejected approval for gepirone in 2002 and 2004. [5]

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New Drug Approvals

JUNE 26, 2025

Food and Drug Administration (FDA). Ma S, Gisselmann G, Vogt-Eisele AK, Doerner JF, Hatt H (October 2008). PMID 19095656. ^ “Alcon Announces FDA Approval of Tryptyr (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease” (Press release). 2008 Oct;21(4):370-8.

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New Drug Approvals

SEPTEMBER 8, 2024

1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 4] Seladelpar was approved for medical use in the United States in August 2024. [1] 1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 4] Seladelpar was approved for medical use in the United States in August 2024. [1]

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. December 2008. [2]

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Drugs Disease Drug Development Clinical Trials 52

New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release). Procedure no.: 22 (4): 3616.

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Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

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FDA FDA Approval Production Regulations 40

New Drug Approvals

APRIL 9, 2025

1] Gepotidacin was approved for medical use in the United States in March 2025. [1] Chemical synthesis The synthesis of gepotidacin has been described in two patents in 2008 and 2016 and comprises 11 steps (Fig. WO2008128942A1 References: GLAXO GROUP LIMITED WO2008/128942, 2008, A1Yield:- Steps: Multi-step reaction with 12 steps 1.1:

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