This gene therapy is the latest in a growing list of rare disease treatments to receive reconsideration from an FDA that appears to be swinging back to regulatory flexibility.
FDA concerns about Amgen’s Tavneos were sparked by securities fraud litigation against ChemoCentryx, the company that originally developed the rare disease drug. The FDA wants to withdraw Tavneos’s approval, citing safety risks and alleged manipulation of the drug’s clinical trial data.
Explore the mindset, cultural shifts, and training strategies that define the AI‑savvy lawyer, revealing why human judgment, standardized competence, and integrated learning—not technology alone—will shape the future of the profession.
One Nation, Overcharged, a campaign backed by the Robert Wood Johnson Foundation, launched to raise awareness of rising healthcare costs.
Rick Pazdur, formerly the FDA’s top oncology official, said the FDA is at a critical juncture that could determine the direction of the world’s top regulator of medicines.
Provider groups largely welcomed the reforms — though some industry leaders said additional changes are still needed to address alleged misuse and improve transparency.
The Massachusetts attorney general sued UnitedHealthcare, alleging the insurer improperly inflated MassHealth members’ health risk scores to secure at least $100 million in excess payments.
Law firms and legal departments are writing the future of the profession in separate rooms. What happens when they actually work together?
Abridge, Highmark Health, and Merck named new executives. There were also layoffs at organizations including Innovaccer, Intermountain Health, and Novartis.
Healthcare organizations urged HHS Secretary Robert F. Kennedy Jr. to protect the U.S. Preventive Services Task Force, warning that disruptions could threaten access to preventive care for millions of Americans.
Three health systems are suing CVS Health, alleging its pharmacy benefit manager diverted roughly $250 million in savings from the 340B program through 'spread pricing' between 2020 and 2025.
Pharmacies and wholesalers claimed Takeda Pharmaceutical delayed generic competition from entering the market, forcing them to overpay for a gastrointestinal drug.
LexisNexis sat down with John Ursin, Managing Partner at Schenck Price, to learn how the firm is using legal AI to strengthen client service and daily legal work.
Employer advocates said Cost Plus Wellness could help spur more direct contracting and transparency in healthcare, though they questioned whether the model can scale and adequately measure provider quality and outcomes.
A coalition of employer and consumer groups is urging the Trump administration to crack down on alleged abuse of the No Surprises Act’s independent dispute resolution process.
Cigna's exit from the ACA individual market is causing one healthcare expert to question the long-term potential of ICHRA.
Healthcare leaders are divided over the Trump administration’s proposed rule to expand employer-sponsored fertility benefits.
Legal experts say the effort signals a broader shift toward data-driven enforcement, as regulators ramp up their scrutiny of telehealth companies and billing automation software.