14 articles tagged with "FDA"
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.
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.
Following modifications to its blood pressure feature, Whoop has successfully avoided further enforcement actions from the FDA.
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 addresses the significant shifts at the FDA, highlighting how competition from China may necessitate a restructuring of the agency.
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.
Telehealth prescribers are now under heightened scrutiny following FDA warnings about compounded weight loss drugs, while Lilly is actively opposing certain compounding practices.
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.
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.
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.
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.