New Drug Approvals

SEPTEMBER 10, 2024

“A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of TAK-041 in healthy participants and patients with stable schizophrenia” British Journal of Clinical Pharmacology. Cilia, Jackie; Hitchcock, Stephen (12 August 2021). X H NMR (500 MHz, DMSO-i¾) δ ppm 1.40 (d, J=6.8 49 (2): 121–132.

Clinical Pharmacology 62

Clinical Pharmacology Small Molecule Pharmacokinetics Pharmaceutical Companies 62

New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. World Health Organization (2021). .; Schneider, Eugene; Guo, Shuling; Henry, Scott; et al. December 2022). PMID 35869634.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology FDA Approval 62

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. 28 October 2021. February 2021). PMID 27092187. Atarashi H, Kuruma A, Yashima M, Saitoh H, Ino T, Endoh Y, et al. August 2000). 2000.108733.

FDA 62

FDA Clinical Trials Treatment Trials 62

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]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. Once metabolized, which occurs quickly with a half-life of approximately 1.5 billion for pseudoephedrine.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

For example, FDA’s Project Renewal was announced in 2021 as a concerted effort to update labeling information for “older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.” In 2021, FDA’s efforts on dose optimization came to the forefront with the announcement of Product Optimus.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40