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. PMID 27092187. Atarashi H, Kuruma A, Yashima M, Saitoh H, Ino T, Endoh Y, et al. August 2000). 68 (2): 14350. doi : 10.1067/mcp.2000.108733. 2000.108733.

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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. . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL.

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Clinical Trials FDA Clinical Pharmacology FDA Approval 62

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

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Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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New Drug Approvals

APRIL 18, 2025

Article ] Rosati G: Clinical pharmacology of iomeprol. 2000 May;59(5):1169-86. doi: 10.2165/00003495-200059050-00013. Article ] Katayama H, Spinazzi A, Fouillet X, Kirchin MA, Taroni P, Davies A: Iomeprol: current and future profile of a radiocontrast agent. Invest Radiol. 2001 Feb;36(2):87-96. doi: 10.1097/00004424-200102000-00004.

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FDA Production FDA Approval Clinical Pharmacology 52

New Drug Approvals

APRIL 21, 2025

. “First-in-Human Study of AG10, a Novel, Oral, Specific, Selective, and Potent Transthyretin Stabilizer for the Treatment of Transthyretin Amyloidosis: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Adult Volunteers” Clinical Pharmacology in Drug Development. 9 (1): 115129.

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FDA Approval FDA Production Treatment 62