FDA Approves Moderna’s New COVID Vaccine With Restricted Use

June 2, 2025 — The FDA has approved Moderna’s new COVID-19 shot, an mRNA vaccine, with some limits on who can get it. The vaccine, called mNexspike, is for people who’ve previously received a COVID-19… Read more

FDA Approves First Oral Treatment for Rare Swelling Disorder

July 8, 2025 – The FDA has approved the first-ever pill to stop attacks of a rare genetic swelling disorder while they’re happening. The drug, known as sebetralstat but sold as Ekterly, is for adults… Read more

FDA OKs First Meningococcal Vaccine for Infants

May 30, 2025 – The FDA has approved the first-ever meningococcal vaccine for babies as young as 6 weeks old. Sanofi Pasteur’s quadrivalent MenQuadfi shot was first cleared in 2020 for adults and children ages 2… Read more

FDA OKs First-of-Its-Kind Lung Cancer Pill

July 7, 2025 – The FDA has granted quick approval to a first-of-its-kind pill for a type of lung cancer known as non-small-cell lung cancer (NSCLC). The drug, called sunvozertinib and sold as Zegfrovy, is… Read more

FDA Approves Novavax COVID Vaccine With Restricted Use

May 19, 2025 – The FDA has approved the Novavax COVID-19 vaccine, a protein-based alternative to mRNA shots, with some limits on who can get it. The vaccine, called Nuvaxovid, is mainly intended for adults 65… Read more

FDA Approves New Long-Term Treatment for Myasthenia Gravis

May 2, 2025 — The FDA has approved a new treatment for generalized myasthenia gravis (gMG), a disease that causes severe muscle weakness, faster muscle fatigue, and difficulty in speaking and swallowing. It offers long-lasting option… Read more

FDA Approves New Treatment for Dry Eye Disease

May 30, 2025 — The FDA has approved a new treatment for dry eye disease (DED) after studies showed it can help stimulate natural tear production as early as the first day of use. The new… Read more

Inlexzo: A New Bladder Cancer Treatment

Inlexzo is a new treatment for a type of bladder cancer in adults that hasn’t spread to the muscles and doesn’t respond to Bacillus Calmette-Guérin (BCG) therapy. It’s approved for treating non-muscle invasive bladder cancer… Read more

FDA Expands Approved Use of Vonvendi

Vonvendi is a lab-made version of von Willebrand factor (VWF), a protein your body needs for blood to clot. Affecting more than 3 million people in the U.S, von Willebrand disease (VWD) is a common… Read more

Tremfya: First Fully Under-the-Skin IL-23 Inhibitor Shot Approved for Ulcerative Colitis and Crohn’s Disease

Tremfya (guselkumab) is a lab-made, dual-acting antibody medication that reduces inflammation by targeting the interleukin-23 (IL-23) protein and blocking a majority of the cells that produce it. It is available by prescription. The FDA has… Read more