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

OCTOBER 20, 2023

Biosimilars are biological products that are highly similar (but not identical) to a previously approved biological product and have “no clinically meaningful” differences relative to the original reference product. Developing biosimilars is an extensive and expensive process.

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Drug Target Review

NOVEMBER 27, 2024

As precision medicines, including RNA interference (RNAi) and oligonucleotide therapies, become more prominent, the importance of advanced techniques in streamlining biomarker validation and expediting the regulatory review process becomes even clearer. Clinical validity: defining biomarker performance. 2010 Jan 1;70(sup242):46-52.

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New Drug Approvals

APRIL 21, 2025

New Drug Therapy Approvals 2024 (PDF). for 10 minutes. The mixture was then heated to 555 C. with stirring. To this mixture was transferred a stirred solution containing 4-fluoro-3-hydroxy-benzoic acid methyl ester (VIIa), potassium carbonate and anhydrous DMSO. 25 November 2024. Retrieved 25 November 2024. ^ January 2025. 9 (1): 115129.

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