A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, issuing 303 Warning Letters to companies involved with drugs and biologics — up 59% from 190 letters in FY2024.
FDA’s Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 2026–2027 U.S. season use a trivalent formulation, targeting two influenza A strains and one influenza B strain.
A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, issuing 303 Warning Letters to companies involved with drugs and biologics — up 59% from 190 letters in FY2024.
FDA’s Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 2026–2027 U.S. season use a trivalent formulation, targeting two influenza A strains and one influenza B strain.
Eli Lilly issues a public warning that its testing found that compounded tirzepatide with vitamin B12 can produce an unknown impurity from a chemical reaction between the two active ingredients.
BridgeBio says its investigational therapy BBP-418 showed consistent clinical benefit and a favorable safety profile in an interim analysis of the Phase 3 FORTIFY trial in patients with limb-girdle muscular dystrophy.
