Section

Policy

FDA, Congress, and the rules that move the industry.

Bound Inflation Reduction Act volume beside a CMS selected-drugs printout and a generic bottle half in shadow, with a courthouse colonnade in shallow background

Policy 18 Aug 2026

What the D.C. Circuit’s Teva ruling actually opened in IRA negotiation — and what it left shut

On 18 August the D.C. Circuit let Teva’s challenge to CMS’s “bona fide marketing” generic test go forward, while upholding CMS’s decision to treat Austedo and Austedo XR as one drug. That is not a repeal. It is a seam.

A circular 2026–27 flu-season calendar stamped FDA approved 5 August and ACIP pending, with an mRNA-lipid nanoparticle schematic behind it

Policy 5 Aug 2026

What FDA approval without an ACIP vote means for Moderna’s first mRNA flu shot

mFLUSIVA is licensed for adults 50 and older as of 5 August, but the committee that usually turns a license into coverage has not met all year — and flu season is weeks away.