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Zydus receives USFDA approval to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with ALS

Express Pharma

This study consists of a 36-week treatment phase, followed by a 16-week open-label extension. 1162 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes, Clinical Pharmacology in Drug Development, 2023, 0(0) 18. DOI: 10.1002/cpdd.1162

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Panel urges FDA to remove warnings on hormonal menopause therapy

BioPharma Dive

Published July 18, 2025 Delilah Alvarado Staff Reporter post share post print email license Food and Drug Administration Commissioner Martin Makary speaks on stage during The Semafor 2025 World Economy Summit on April 24, 2025 in Washington, DC. Many, however, were already on the record holding similar views as Makary on the warning label.

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Biogen and Eisai’s Alzheimer’s drug secures support in closely watched AdCom

Pharmaceutical Technology

The evidence for clinical benefit was “very clear”, said Dr. Merit Cudkowicz, Julieanne Dorn professor of neurology at Harvard University’s Medical School. Leqembi is the second drug developed by Biogen and Eisai for the treatment of Alzheimer’s disease.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

She also has been conducting fundamental research as an academic in several universities, with her last academic position held at Harvard Medical School. US Food and Drug Administration. She holds a MSc in Public Health and a PhD in Biophysics and Molecular Biology. About the author. References. Risk management plan [Internet].

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Covid-19 vaccine success bolsters nanoparticle drug delivery research

Pharmaceutical Technology

In an email to this news service, João Conde, PhD, professor at NOVA Medical School, Universidade NOVA de Lisboa, said advances like the mRNA vaccines serve as a testament to the breakthroughs made by science over decades of research at the junction of genetics and nanomedicine.