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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 Supra2h
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 ...
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 ...
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.
Cure Today6d
FDA Grants Priority Review to Sunvozertinib for EGFR Exon20+ NSCLC
The Food and Drug Administration has accepted and granted priority review to a new drug application for sunvozertinib.
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 ...
Outgoing FDA chief flags online weight loss drug dangers
Current laws and regulations are not enough to protect Americans from the risks of compounded versions of popular weight loss ...
Dayton Daily News6d
FDA reviews reports of dog illnesses, death connected to arthritis drug
The U.S. Food and Drug Administration is reviewing reports that more than 1,000 dogs died in an 18-month span after taking an arthritis drug called Librela.
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 ...