Drugs and Medications Approvals and Updates
- FDA OKs New Steroid-Free Skin Cream for Hand Eczema
July 23, 2025 — The FDA has approved a new treatment, sold under the name Anzupgo and containing a drug called delgocitinib, as the first skin cream for adults with long-term or chronic hand eczema (CHE), which affects about 1 in every 10 people globally.
- FDA OKs Moderna’s COVID Shot for Kids, With Limits
July 11, 2025 — The FDA has given full approval to Moderna's COVID-19 shot, Spikevax, allowing it to be used in children 6 months to 11 years old, with some limits on who can get it.
- FDA Approves First Oral Treatment for Rare Swelling Disorder
July 7, 2025 — The FDA has approved sebetralstat (sold as Ekterly), the first-ever pill for people 12 and older with hereditary angioedema, a rare genetic disorder that causes sudden and painful swelling that can sometimes be life-threatening.
- FDA OKs First-of-Its-Kind Lung Cancer Pill
July 6, 2025 — The FDA has granted quick approval to sunvozertinib (sold as Zegfrovy) a first-of-its-kind pill for a type of lung cancer known as non-small-cell lung cancer (NSCLC).
- FDA Greenlights New Treatment for Advanced Blood Cancer
July 3, 2025 — A new treatment has received a quick federal nod for a common blood cancer, which could affect more than 36,000 people and result in around 12,000 deaths in the U.S. this year alone.
- FDA Approves First Twice-Yearly Shot to Prevent HIV
June 18, 2025 — The FDA has approved the first twice-yearly shot to reduce the risk of HIV infections.
- FDA OKs New Monthly Treatment for Rare Swelling Disorder
June 18, 2025 — The FDA has approved a first-of-its-kind treatment for a rare genetic condition that causes frequent, unpredictable, and painful swelling in different parts of the body.
- FDA OKs New Next-Gen Pill for Rare Lung Cancer
June 11, 2025 — The FDA has approved an oral pill called taletrectinib (Ibtrozi) to treat people who have a rare type of non-small-cell lung cancer (NSCLC) that is linked to a faulty ROS1 gene and has spread or worsened.
- FDA Approves New 3-in-1 Combo Pill for High Blood Pressure
June 10, 2025 — The FDA has approved a new pill called Widaplik, which combines three drugs – telmisartan, amlodipine, and indapamide – to treat adults who have high blood pressure.
- FDA OKs New Shot to Protect Babies Against RSV
June 9, 2025 — The FDA has approved clesrovimab -- sold as Enflonsia -- a new shot to prevent respiratory syncytial virus (RSV) infection in babies during their first RSV season, which typically lasts from fall through spring.
- 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 called mNexspike, with some limits on who can get it.
- FDA Approves New Treatment for Dry Eye Disease
May 30, 2025 — The FDA has approved Tryptyr (acoltremon) as the first TRPM8-targeting eye drop for dry eye disease, stimulating natural tear production as early as day one.
- FDA OKs First Meningococcal Vaccine for Infants
May 29, 2025 — The FDA has approved MenQuadfi as the first-ever meningococcal vaccine for babies as young as 6 weeks old. It protects against invasive meningococcal disease (IMD) caused by meningococcal bacteria (Neisseria meningitidis) strains A, C, W, and Y.
- FDA OKs Nucala for Hard-to-Treat COPD
May 23, 2025 — The FDA has approved the asthma drug Nucala for adults with chronic obstructive pulmonary disease (COPD).
- FDA Approves Novavax COVID Vaccine With Restricted Use
May 18, 2025 — The FDA has approved the Novavax COVID-19 vaccine, called Nuvaxovid, mainly for adults 65 or older, but people ages 12 to 64 with medical conditions that increase their risk of serious illness from COVID can also get the shot.
- FDA Approves New Long-Term Treatment for Myasthenia Gravis
May 1, 2025 — The FDA approves Imaavy, a groundbreaking treatment for generalized myasthenia gravis (gMG), offering symptom relief and reduced autoantibody levels in adults and children over 12.