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Arrowhead’s plozasiran set for FDA review as Tryngolza challenge looms
An FDA approval later this year for Arrowhead’s plozasiran in FCS would put it in direct competition with Ionis’ Tryngolza.
JD Supra1h
Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
Sweeping review suggests weight-loss drugs’ effect on 175 conditions
The findings, based on an analysis of records from 2.5 million VA patients, support much of what scientists already suspected ...
The American Journal of Managed Care4h
In a First-of-Its-Kind Decision, FDA Will Allow Marketing of Nicotine Pouches
This marketing decision from the FDA covers 2 nicotine strengths, 3 mg and 6 mg, and 10 flavors of the small tobacco-free ...
JD Supra4h
FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations
The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization ...
FDA’s START and CoGenT pilot programmes: Streamlining rare disease drug approvals
These initiatives represent a way to accelerate access to treatments that have historically faced longer regulatory pathways.
CergenX wins FDA breakthrough designation for neonatal EEG assessment tool
Trained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...
drugtargetreview.com5h
Obstacles and innovations of macrocyclic drug development
Discover the potential of macrocycles in drug discovery: flexible, cell-permeable molecules targeting undruggable proteins.
SiliconRepublic10h
CergenX making Waves with new FDA designation
Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...
RFK Jr. wants to improve Americans’ health. Here’s some advice from the outgoing FDA chief
Robert F. Kennedy Jr. has big plans for the FDA if he's confirmed as Secretary of Health and Human Services. FDA Commissioner ...
drugtargetreview.com11h
FDA’s Project Optimus: A new era in oncology drug dosing
Discover how precision medicine and FDA's Project Optimus are transforming clinical trials in oncology drug development.