Pharmaceutical Technology on MSN12h
Soleno wins FDA approval for Prader-Willi hyperphagia treatment
Soleno Therapeutics has won US Food and Drug Administration (FDA) approval for diazoxide choline – which will be branded as ...
JD Supra12h
FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers
Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The ...
The Scientist2d
IND Applications Are Tedious. Can AI Help?
Drug developers can now leverage large language models to draft regulatory documents, which they hope will shorten the time ...
Glioma Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight’s, “Glioma Pipeline Insight, 2025” report provides comprehensive insights about 180+ companies and 200+ pipeline ...
Larimar Therapeutics Provides Nomlabofusp Development Update and Reports Fourth Quarter and Full Year 2024 Financial Results
FDA stated in written correspondence for a START pilot program meeting that it is open to considering skin FXN concentration as a reasonably ...
Novartis7d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...
Radio Iowa7d
Bill would O.K. synthetic psilocybin prescriptions in Iowa, if FDA clears use
A bill under consideration in the legislature would position Iowa to immediately allow prescriptions of a synthetic version ...
AOL10d
Mother with rare ALS touts 'miracle drug' that has stopped her disease
Raziel Green, 52, an active runner and mother of two, was diagnosed with a rare form of ALS in 2017 ... Soon after her diagnosis, Green learned about a clinical trial at Mass General for an ...
Queerty14d
A once-a-year PrEP injection? The results of the first clinical trial look promising
Pharma giant Gilead Sciences has revealed the results of its first, Phase 1 trial into a once-a-year PrEP injection. The ...
Yahoo Finance15d
FDA Study May Proceed Notice Received for Phase 2 Trial of TPST-1495 for the Treatment of Familial Adenomatous Polyposis (FAP)
BRISBANE, Calif., March 13, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class 1 targeted and immune-mediated ...
BioSpace15d
FDA Study May Proceed Notice Received for Phase 2 Trial of TPST-1495 for the Treatment of Familial Adenomatous Polyposis (FAP)
BRISBANE, Calif., March 13, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class 1 targeted and immune-mediated ...