Business Wire10h
U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced that the U.S. Food and Drug Administration (FDA) ...
The American Journal of Managed Care16h
TROPION-Breast01: Datopotamab Deruxtecan Improves Progression-Free Survival
Aditya Bardia, MD, MPH, FASCO, medical oncologist, UCLA Health, discusses findings from the TROPION-Breast01 study on ...
Healio17h
FDA approves Evrysdi tablets for spinal muscular atrophy
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
Managed Healthcare Executive1d
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...
The Boston Globe16d
Member of Lynn drug gang posing as rap label to plead guilty to RICO charges, records show
A reputed member of a Lynn-based drug gang that poses as a rap music label will plead guilty to federal racketeering charges in connection with the group’s activities, including murder ...
JD Supra18d
FDA Releases Proposed Front-of-Package Nutrition Labeling Rule
the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) nutrition labeling (“proposed rule”). 1 If finalized, the ...
Medscape20d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
Renu Lal, Pharm.D., is Scientist, Genentech, Inc.; when this article was written she was Team Leader, Division of Drug Information, Office of Training and Communications, Center for Drug ...
NBC News23d
Federal regulations paused, halting FDA's proposed ban on formaldehyde in hair products
The Food and Drug Administration announced it would decide by April 2024 whether chemical hair straightening products sold in the U.S. would be banned from using formaldehyde or ingredients that ...
WLRN23d
How labeling cartels ‘terrorists’ could hurt the U.S. economy
The executive order, which Trump signed Monday, is intended to apply maximum pressure on Mexico to rein in its dangerous drug trade ... The terrorist label could also push big parts of Mexico ...
Yahoo Finance23d
J&J’s Spravato receives FDA label expansion for depression monotherapy
Initially approved in 2019 for use alongside oral antidepressants, this label expansion follows a priority review from the FDA. The approval was based on data from the Phase IV TRD4005 study ...
Newsweek24d
FDA Approves Nasal Spray for Depression
The nasal spray Spravato, which is made from the drug esketamine, had been approved in 2019 for patients who failed to respond to at least two oral antidepressants. However, it had to be used in ...
CNN24d
FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression ...