Blog FDA Approval Pharmacokinetics 
Metabolite Tales Blog
APRIL 10, 2024
It is approved for treatment of severe alopecia areata in which inflammatory processes play a major role, with associated increased reactive oxygen species formation and reduced levels of GSH. The next blog will complete our commentary on metabolism of small molecule drugs approved in 2023. Clin Pharmacokinet.
Metabolite Tales Blog
APRIL 4, 2023
Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Dermavant’s tapinarof is one such friend. 8 This is not the only point of interest.
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Metabolite Tales Blog
JANUARY 23, 2024
Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. link] [10] FDA prescribing information for gepirone. Pharmacokinetics and Metabolism of Nirmatrelvir.
The Premier Consulting Blog
APRIL 15, 2024
In this blog, we will go into more detail about the unwritten nonclinical requirements for the PIND meeting.
PerkinElmer
JANUARY 7, 2022
There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. Furthermore, nearly one third of drugs get withdrawn from the market post approval due to safety concerns. link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet].
New Drug Approvals
DECEMBER 24, 2023
2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. Food and Drug Administration (FDA).
New Drug Approvals
OCTOBER 24, 2023
Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] “FDA Approves New Drug for Ulcerative Colitis” Medscape.
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