#FDA
15 articles tagged with "FDA"
FDA Approves Philip Morris to Market Zyn as a Safer Alternative to Cigarettes
The FDA has granted Philip Morris approval to promote Zyn as a less harmful option compared to traditional cigarettes, signaling a notable change in nicotine product marketing.
Key Developments in Healthcare Legislation: 340B Program and FDA Leadership
Recent discussions highlight significant changes proposed for the 340B program and the introduction of new candidates for the FDA commissioner role, with potential impacts on public health.
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.
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.
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.
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.
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.
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.
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.
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.
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.