The US Supreme Court is set to hear one case this term that could bolster the biopharma industry’s ability to challenge US Food and Drug Administration rules and it is likely to take up another case that would undermine industry's reliance on agency decisions.
Mifepristone Ruling Casts ‘Shadow Of Uncertainty’ Over Every FDA Approval, Biopharma Industry Tells Supreme Court
As the new Supreme Court term begins, PhRMA and a host of biopharma CEOs and investors implore justices to take up mifepristone case to prevent chaos for drug development. High court will also consider a lawsuit that would reduce deference to federal rulemaking and it may consider another that would increase corporate liability under the Anti-Terrorism Act.

More from Legal & IP
Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.
Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?
An HHS legal brief argues company lawsuits seeking immediate clearance to use rebates in 340B are premature and that the department has merely used a ‘measured approach’ in weighing the possibility. Past experience suggests otherwise, a pricing expert said.
The Health and Human Services Department's decision to eliminate the Richardson Waiver may be a blow for transparency, but will not completely eliminate scrutiny of regulations, experts said.
More from Pink Sheet
Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.