FDA Approval Pharmacokinetics Regulations 
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.
Drug Target Review
SEPTEMBER 19, 2023
This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. To this end, the FDA’s newly created iSTAND initiative drives the path toward regulatory approval for devices like organ-on-chips.
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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.
The Pharma Data
MAY 17, 2023
BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS.
The Pharma Data
OCTOBER 25, 2020
“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI.
Agency IQ
SEPTEMBER 15, 2023
BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,
The Pharma Data
DECEMBER 29, 2020
Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. About Fabry Disease. Galactosidase-A enzyme.
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