Medscape2d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
Purpose: The revised prescription drug labeling ... products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug ...
Cure Today27d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The Food and Drug Administration (FDA) has accepted a new drug application (NDA) with priority review for the investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) taletrectinib in the ...
JD Supra13d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
Business Wire1mon
Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism
has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous ...
GSK announces new drug applications accepted for review in China, Japan
GSK (GSK) announced that new drug applications have been accepted for review by the China National Medical Products Administration and ...