#FDA
10 articles tagged with "FDA"
Roche's Strong Accusations Against U.S. Drug Review Practices Raise Concerns
Roche has leveled serious accusations against the U.S., claiming 'blackmail' tactics amid ongoing controversies surrounding drug reviews and skinny labels.
Editorial Staff 10 days ago
Rick Pazdur on FDA's Challenges and Opportunities Amidst China's Rising Competition
Rick Pazdur addresses the significant shifts at the FDA, highlighting how competition from China may necessitate a restructuring of the agency.
Editorial Staff 16 days ago
Replimune's Drug Faces Third FDA Approval Attempt Amid Pfizer's New Deal in China
Replimune is set to make a third attempt for FDA approval of its drug, while Pfizer has recently secured a deal in China, highlighting ongoing developments in the pharmaceutical sector.
Editorial Staff 17 days ago
Increased Scrutiny for Telehealth Prescribers and Lilly's Compounding Concerns
Telehealth prescribers are now under heightened scrutiny following FDA warnings about compounded weight loss drugs, while Lilly is actively opposing certain compounding practices.
Editorial Staff Updated 18 days ago
Kyle Diamantas Takes the Helm of FDA's Food Division Amid Uncertainty
In 2025, a relatively unknown attorney from Florida was appointed as the FDA's top food official, raising questions about his ability to lead in a critical regulatory environment.
Editorial Staff 20 days ago
Concerns Rise Among Biotech Leaders Over FDA Leadership Changes and Their Effects on Rare Disease Drugs
The recent departure of significant FDA officials has sparked worries among biotech executives about the future of rare disease drug development, emphasizing the need for regulatory stability.
Editorial Staff 26 days ago
Trump Suggests Reevaluation of Kratom Derivative 7-OH Amid FDA Concerns
In a notable shift, President Trump has indicated that certain forms of the kratom derivative 7-OH may warrant approval, despite prior warnings from the FDA about its risks.
Editorial Staff about 1 month ago