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.
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 ...
Cure Today5d
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.
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 ...
JD Supra44m
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 ...
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 ...
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 ...
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.