A new analysis by Milliman commissioned by PhRMA indicates that 3.5 million Medicare Part D beneficiaries could face an average 12 percent increase in annual out-of-pocket costs in 2026 due to the Inflation Reduction Act’s (IRA) drug pricing provisions. Read More

The FDA on Tuesday approved Kisunla (donanemab-azbt), Eli Lilly’s once-monthly injection for adults with early symptomatic Alzheimer's disease (AD), along with earlier approvals of four other drugs for various conditions. Read More

The FDA has issued a complete response letter (CRL) to Rocket Pharmaceuticals requesting additional chemistry, manufacturing and controls (CMC) information before reviewing the company’s BLA for Kresladi (marnetegragene autotemcel). Read More

The Supreme Court voted 6-3 on Monday to lay out a new standard that makes it easier for companies and other entities to challenge federal rules, potentially allowing new challenges to regulations that have been in place for decades. Read More

Three former executives of Chicago-based tech startup Outcome Health have been sentenced for their roles in a six-year scheme involving approximately $1 billion in fraudulently obtained funds gained from a pharmaceutical advertising scheme. Read More

Hoau-Yan Wang, a former paid consultant at Cassava Science and professor at the City University of New York (CUNY), is now the subject of a federal indictment charging that he milked the NIH for $16 million in grant money based on falsified data. Read More

The Supreme Court’s reversal of a 40-year-old precedent that had smoothed the regulatory agency pathway now makes it easier for courts to step in with their own interpretation of a law’s effect on regulatory issues. Read More

The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Read More

Assuring the consistent performance of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1. Read More