Remove 2026 Remove Dosage Remove Drug Pricing
article thumbnail

AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

FDA Law Blog: Biosimilars

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. at least one drug” has been approved and marketed. The court found numerous flaws with this argument.

Dosage 64