Whoop Avoids FDA Enforcement After Blood Pressure Feature Adjustments
Following modifications to its blood pressure feature, Whoop has successfully avoided further enforcement actions from the FDA.
Editorial Staff 3 days ago
#FDA
12 articles tagged with "FDA"
Eli Lilly's Compassionate Use Program Grants Access to Experimental Obesity Drug for 79-Year-Old
In a notable case, Eli Lilly and the FDA have provided a 79-year-old patient with access to an experimental obesity drug through the compassionate use program, highlighting ethical considerations in drug access.
Editorial Staff 4 days ago
Exploring New Frontiers in Obesity Medications and Peptide Treatments
The landscape of obesity medications is evolving, with new drugs entering the market and peptides gaining traction in treatment protocols. The FDA's decisions will be pivotal.
Editorial Staff 15 days ago
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 22 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 28 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 29 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 30 days ago
FDA Delays Decision on AstraZeneca's Breast Cancer Treatment Following Panel Vote
The FDA has postponed its decision on AstraZeneca's experimental breast cancer pill after an advisory panel voted against its approval, signaling further review is needed.
Editorial Staff about 1 month 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 about 1 month 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 about 1 month ago
Concerns Grow as FDA Drug Center Head Tracy Beth Høeg Resigns
Tracy Beth Høeg's resignation from the FDA's drug center follows the recent departure of Commissioner Marty Makary, highlighting a troubling leadership gap within the agency.
Editorial Staff about 1 month 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 2 months ago