February 21, 2025

FDA Approves First Cerebrotendinous Xanthomatosis Treatment

The FDA has approved Ctexli (chenodiol) as the first treatment for cerebrotendinous xanthomatosis, a rare lipid storage disorder.

Conexiant

February 21, 2025

FDA Ends Semaglutide Shortage, Updates Policy

FDA declares resolution of nationwide semaglutide injection shortage and outlines 60 to 90 day transition periods for compounding facilities while other GLP-1 medications remain in limited supply.

Conexiant

February 21, 2025

CDC: Measles Cases Surge Amid Texas Outbreak

Measles cases in the U.S. surged from 14 to 93 in one week, with 95% of infections in unvaccinated or immunity-unknown individuals, per the CDC.

Reuters

February 20, 2025

NY Sues Major Vape Distributors Over Youth Marketing

Attorney General Letitia James files lawsuit against 13 e-cigarette companies for allegedly targeting minors with flavored nicotine products, seeking hundreds of millions in damages and penalties.

Conexiant

February 19, 2025

FDA Approves Amneal’s Lenalidomide; Mesalamine 800 mg Launched

Mesalamine 800 mg delayed-release tablets have been launched, and FDA approval has been granted for lenalidomide, with plans for entry into the U.S. generic market in 2026.

Conexiant

February 18, 2025

FDA Clears Aptima SARS-CoV-2 Assay for High-Throughput Testing

FDA grants 510(k) clearance for Hologic’s Aptima SARS-CoV-2 assay, which uses the Panther system for high-throughput RNA detection.

Conexiant

February 18, 2025

FDA Qualifies Two-Level RDL for AUD Trials

The drug development tool offers an alternative, clinically meaningful endpoint in clinical trials that evaluate pharmacologic treatments for alcohol use disorder.

Conexiant

February 17, 2025

FDA Approves GSK’s 5-in-1 MenABCWY Vaccine

FDA approves GSK’s Penmenvy, a 5-in-1 meningococcal vaccine for adolescents and young adults, targeting five major serogroups of Neisseria meningitidis that cause invasive meningococcal disease.

Conexiant

February 17, 2025

FDA Approves GSK’s 5-in-1 MenABCWY Vaccine

FDA approves GSK’s Penmenvy, a 5-in-1 meningococcal vaccine for adolescents and young adults, targeting five major serogroups of Neisseria meningitidis that cause invasive meningococcal disease.

Conexiant