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 ...
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 ...
SiliconRepublic7h
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 ...
The American Journal of Managed Care1h
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 Supra1h
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 ...
JD Supra48m
FDA Proposes Limiting Nicotine Levels in Cigarettes and Certain Other Combusted Tobacco Products
On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in ...
Sweeping review suggests effect of weight-loss drugs on 175 conditions
The findings, based on an analysis of records from 2.5 million VA patients, support much of what scientists already suspected ...
drugtargetreview.com8h
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.
drugtargetreview.com2h
Obstacles and innovations of macrocyclic drug development
Discover the potential of macrocycles in drug discovery: flexible, cell-permeable molecules targeting undruggable proteins.
localnewsmatters22h
Newsom committed California to making its own insulin. It’s a year behind his schedule
Gov. Gavin Newsom’s ambitious plan to produce a cheap, generic insulin for the 3.2 million Californians with diabetes is behind the schedule he announced ...
Health on MSN6h
10 Conditions Turmeric Can Help With
Turmeric's active compound, curcumin, is a potent anti-inflammatory and antioxidant that can help with conditions like ...