New Drug Approvals

APRIL 19, 2025

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. “The selectivity of beta-adrenoceptor antagonists at the human beta1, beta2 and beta3 adrenoceptors” British Journal of Pharmacology.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. Four comments were submitted to the docket established for the 2015 Petition. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine.

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Agency IQ

FEBRUARY 23, 2024

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. Whereas the prior workshops focused on certain types of therapies or the use of combination products, this newest workshop was designed to discuss “quantitative approaches to select dosages for clinical trials.”

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Agency IQ

DECEMBER 11, 2023

As a result, products receiving approval due to their demonstrated safety and efficacy in the clinical trial setting may lack real-world effectiveness, with patients failing to see material benefit as they deal with persistent and severe side effects.

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Drug Target Review

JANUARY 20, 2025

This approach underlies the identification of the OBD, backed by both clinical efficacy and drug tolerability data. Pharmacologically-guided dosing : Integrating pharmacokinetics (PK), pharmacodynamics (PD), and translational biomarkers into dose selection tailors drug administration regimens that maximize the therapeutic index of a drug.

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New Drug Approvals

APRIL 18, 2025

January 2015). Article ] Rosati G: Clinical pharmacology of iomeprol. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. Pfundstein P, Martin C, Schulz W, Seitz W, Ruth KM, Wille A, et al. 2000 May;59(5):1169-86. 2000 May;59(5):1169-86.

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