2011 Clinical Pharmacology Therapies 
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. New Drug Therapy Approvals 2024 (PDF). “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al.
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
FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. Since the 2007 NDAC meeting, several clinical trials have been conducted by industry to assess new phenylephrine doses and formulations—consistently failing to outperform placebo.
Agency IQ
OCTOBER 6, 2023
As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. This was more than twice the volume seen in FY 2022 and the second highest percentage of novel drug approvals in a given year dating back to 2011. of all NME approvals this year.
The Pharma Data
FEBRUARY 8, 2021
1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). v] ERLEADA ® is being studied in five Phase 3 clinical trials. . ‡ FDA on April 28, 2011 and by the European Commission on September 7, 2011. percent in the control arm. percent vs. 3.9
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