Senate confirms Marty Makary to lead FDA
The Senate on Tuesday night confirmed Marty Makary to be the Food and Drug Administration commissioner. Makary was easily ...
Theratechnologies Receives FDA Approval for EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy
New, improved formulation set to replace EGRIFTA SV®MONTREAL, March 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or ...
MassDevice10h
How to design medtech clinical trials that deliver
Transparent, well-designed clinical trials are a must. FastWave Medical's Scott Nelson has advice on how to get there.
The Scientist13h
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 ...
FDA approves Tremfya for active Crohn's disease in adults
The U.S. Food and Drug Administration has approved Johnson & Johnson's Tremfya (guselkumab) for adult patients with ...
The Manila Times1d
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 ...
Novartis5d
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 Iowa5d
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 ...
Longeveron Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer's Disease
Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer's diseaseAlignment with FDA on proposed trial study design ...
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. Since starting a ...
Queerty12d
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 ...