Articles related to REGULATORY AFFAIRS

Ocular Therapeutix announced FDA alignment on a planned fourth-quarter 2026 NDA submission for Axpaxli in wet AMD, based on SOL-1 phase 3 efficacy data and interim safety results from the ongoing SOL-R trial.

The FDA expanded approval of Capvaxive, a pneumococcal 21-valent conjugate vaccine, to children and adolescents aged 2 to 17 years with at least one chronic medical condition increasing pneumococcal disease risk, based on STRIDE-13 trial data showing noninferiority to PPSV23 across 12 shared serotypes and statistically significantly higher OPA GMTs for 9 serotypes unique to Capvaxive.

ASHP urged HRSA in a June 2 letter to take immediate enforcement action against Eli Lilly after the manufacturer gave an initial group of 340B-covered entities five business days to submit detailed claims-level data or lose access to discounted pricing across its full drug portfolio, including in-house hospital pharmacy dispensing and medically administered products; as of mid-June, the threatened cutoffs had not yet taken effect for many affected entities.

The Main Street Pharmacy Access Act (H.R. 3164/S. 2426), which would authorize Medicare reimbursement for pharmacist-provided testing and treatment of flu, strep, RSV, and COVID-19 in states that already permit those services, cleared the House Committee on Ways and Means on May 21 with more than 110 congressional co-sponsors and support from over 170 organizations.

Breckenridge Pharmaceutical initiated a voluntary Class II recall of duloxetine delayed-release capsules 60 mg (Lot 241069C, expiration May 31, 2027) on April 21, 2026, following detection of elevated N-nitroso-duloxetine impurity levels attributed to CGMP deviations at the Barcelona manufacturing site, affecting 165,761 bottles distributed nationwide.

ACOG released its first maternal immunization schedule formally diverging from federal vaccine recommendations, following its February 2026 withdrawal from the CDC Advisory Committee on Immunization Practices over concerns about the committee’s scientific integrity.