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Management: Food and Drug Administration (FDA)
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Total 7411 results found since Jan 2013.
New Non-Steroidal Topical Therapies for Inflammatory Dermatoses-Part 2: Tapinarof
Skinmed. 2023 Aug 28;21(3):177-181. eCollection 2023.ABSTRACTSince its introduction in 1952, topical glucocorticosteroids remain the initial and long-term treatment option for various forms of inflammatory dermatitis. A number of non-steroidal topicals for treating inflammatory dermatoses have been developed in the recent decades (such as topical calcineurin inhibitors, vitamin D analogues, and phophodiesterase-4 inhibitors), but none had the combination of broad therapeutic range, relatively rapid onset of action, high tolerability, and wide-spread clinical success; this allowed topical glucocorticosteroids to remain the ...
Source: Skinmed - August 27, 2023 Category: Dermatology Authors: Margaret DiRuggiero Elizabeth Mancuso-Stewart Douglas DiRuggiero Matt Zirwas Source Type: research
Investigation of immunogenicity assessment of biosimilar monoclonal antibodies in the United States
Clin Pharmacol Ther. 2023 Aug 27. doi: 10.1002/cpt.3033. Online ahead of print.ABSTRACTImmunogenicity is critical for biologics. However, reference biologics labeling documents do not necessarily mention immunogenicity impact, rendering the development of biosimilars more challenging. We aimed to investigate the comparative assessment of immunogenicity profiles between biosimilars and their respective reference biologics in the review reports of the biosimilar monoclonal antibody applications approved by the Center for Drug Evaluation and Research, United States Food and Drug Administration (USFDA) as of March 13, 2022, co...
Source: Clinical Pharmacology and Therapeutics - August 27, 2023 Category: Drugs & Pharmacology Authors: Ching-An Cheng Ai-Lei Jiang Yu-Ru Liu Lin-Chau Chang Source Type: research
New Non-Steroidal Topical Therapies for Inflammatory Dermatoses-Part 2: Tapinarof
Skinmed. 2023 Aug 28;21(3):177-181. eCollection 2023.ABSTRACTSince its introduction in 1952, topical glucocorticosteroids remain the initial and long-term treatment option for various forms of inflammatory dermatitis. A number of non-steroidal topicals for treating inflammatory dermatoses have been developed in the recent decades (such as topical calcineurin inhibitors, vitamin D analogues, and phophodiesterase-4 inhibitors), but none had the combination of broad therapeutic range, relatively rapid onset of action, high tolerability, and wide-spread clinical success; this allowed topical glucocorticosteroids to remain the ...
Source: Skinmed - August 27, 2023 Category: Dermatology Authors: Margaret DiRuggiero Elizabeth Mancuso-Stewart Douglas DiRuggiero Matt Zirwas Source Type: research
