FDA actions, approvals, policy shifts, and compliance—how rules change timelines and probability.
The Trump administration has opted for a distinct approach to responding to the expanding Ebola outbreak, deviating from the comprehensive pandemic preparedness blueprint established under the Biden administration.
The Trump administration has opted for a distinct approach to responding to the expanding Ebola outbreak, deviating from the comprehensive pandemic preparedness blueprint established under the Biden administration.
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Replimune Resubmits Its RP1 Melanoma Immunotherapy for FDA Approval Following Departure of Previous Decision Makers.
The Trump administration unveiled a comprehensive proposal to fundamentally change the regulations governing federal grants, stirring uncertainty and concern in the research community.
The Massachusetts Attorney General has filed a lawsuit against UnitedHealthcare, accusing the insurer of fraudulent practices by inflating the health risks of Medicaid members to increase profits.
The FDA's recent relaxation of oversight on wellness devices has resulted in a marked increase in the availability of wearables claiming to monitor blood pressure, many of which lack proper validation.
The FDA has accepted BridgeBio’s new drug application for BBP-418, a potential first treatment for limb-girdle muscular dystrophy, under priority review, a critical advancement for the muscular dystrophy field.
AstraZeneca’s oral SERD drug camizestrant encountered a negative vote from an FDA advisory committee, delaying its approval for advanced breast cancer patients.
The FDA convenes its vaccine advisory panel to discuss updates to the COVID-19 vaccine formulation, signaling ongoing vigilance in pandemic response.
Takeda Pharmaceutical is challenging a jury verdict that ordered the company to pay $885 million for allegedly delaying generic competition, a practice known as 'pay-for-delay,' which keeps drug prices high.
Mount Sinai, Michigan Medicine, and the University of Kansas Health System have filed a lawsuit against CVS Health, accusing the pharmacy benefit manager of diverting substantial savings from the federal 340B drug pricing program.
A recent report highlights a sharp increase in the use and spending on GLP-1 medications among adolescents from 2022 to 2025, raising important considerations for self-insured employers.
