September 25th 2025
FDA approves Eli Lilly’s Inluriyo (imlunestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed after endocrine therapy.
FDA Fast Tracks Sanofi’s Intravitreal Gene Therapy for Neovascular Age-Related Macular Degeneration
September 11th 2025The designation supports expedited development of SAR402663, Sanofi’s one-time gene therapy designed to reduce treatment burden and slow vision loss in patients with wet age-related macular degeneration.
FDA Authorizes New COVID Vaccines with Restrictions on Eligibility
August 27th 2025FDA approves COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax targeting the LP.8.1 sublineage of SARS-CoV-2, with eligibility limited to adults aged 65 years and older and those with underlying medical conditions that place them with a high risk for severe disease.
Lawsuits Likely as Federal Authorities Roll Back Longstanding Vaccine Guidelines
August 19th 2025Ron Lanton, partner, Lanton Law, warns that recent changes to federal vaccine recommendations could trigger extensive litigation as insurers, providers, and patients face new access and coverage challenges.