Drugs and Medications Approvals and Updates
- FDA Approves New Non-Opioid, Once-Daily Bedtime Tablet for Fibromyalgia Pain and Sleep Disturbance
August 18, 2025 — Tonmya (cyclobenzaprine) is a non-opioid medicine approved by the FDA to treat fibromyalgia in adults.
- Papzimeos: First Approved Immunotherapy for Recurrent Respiratory Papillomatosis in Adults
August 15, 2025 — Papzimeos (zopapogene imadenovec-drba) is a new type of immunotherapy approved to treat adults with recurrent respiratory papillomatosis (RRP).
- Brinsupri: First Once-Daily Tablet for Non-Cystic Fibrosis Bronchiectasis
August 13, 2025 — Brinsupri (brensocatib) is a new oral medicine approved to treat a long-term lung disease known as non-cystic fibrosis bronchiectasis (NCFB) in adults and children ages 12 or older.
- Hernexeos (Zongertinib) Approved as the First Oral Targeted Treatment for HER2-Mutant Advanced Lung Cancer
August 11, 2025 — Hernexeos (zongertinib) is a new pill for adults with a type of advanced lung cancer called non-small-cell lung cancer (NSCLC) that has a HER2 gene mutation that causes the cancer to grow and spread faster, especially to the brain.
- Modeyso (Dordaviprone) as First Treatment for Recurrent H3 K27M-Mutant Diffuse Midline Glioma
August 7, 2025 — Modeyso (dordaviprone) is a new oral medicine that treats a rare and aggressive brain tumor, called diffuse midline glioma (DMG), that has a tumor mutation known to promote tumor growth, called an H3 K27M mutation.
- Ajovy Approved as a First-of-Its-Kind Shot for Preventing Migraine in Children and Teens
August 6, 2025 — Ajovy (fremanezumab) is a medicine approved to help prevent migraines. It is a lab-made monoclonal antibody that blocks a protein called calcitonin gene-related peptide.
- Leqvio: New Injectable Option for Lowering Bad Cholesterol Without Statins
August 4, 2025 — Leqvio (inclisiran) is a prescription injection that helps lower levels of low-density lipoprotein cholesterol (LDL), often called “bad” cholesterol, which is a major risk factor for heart disease, heart attack, and stroke.
- Vizz: New Daily Eye Drop to Improve Age-Related Blurry Near Vision
August 4, 2025 — Vizz (aceclidine ophthalmic solution) is a new prescription eye drop approved to treat presbyopia, a common condition that makes it harder to see things up close as you get older. It's the first eye drop in the U.S. to use aceclidine.
- Alhemo: A New Daily Injection to Help Prevent Bleeding in Hemophilia A and B
August 4, 2025 — Alhemo (concizumab-mtci) is a medicine approved to help prevent bleeding in people aged 12 or older with hemophilia A or B who don’t have inhibitors to certain blood clotting proteins.
- Empaveli: A New Treatment Option for Rare Immune-Related Kidney Diseases
July 30, 2025 — Empaveli (pegcetacoplan) is now approved as the first targeted medicine for adults and children aged 12 years or older with two rare and serious kidney diseases: complement component 3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC‑MPGN).
- Skytrofa Approved as Once-Weekly Option for Adults With Growth Hormone Deficiency
July 29, 2025 — Skytrofa (lonapegsomatropin-tcgd), a long-acting version of human growth hormone (hGH), is now approved for adults with GHD.
- New Oral Treatment for Adults and Children With Phenylketonuria: Sephience
July 29, 2025 — Sephience (sepiapterin) is a new oral medication approved by the FDA to treat a rare inherited condition known as phenylketonuria (PKU) in adults and children aged 1 month or older.
- New Oral Option for Children With Low Platelet Counts: Doptelet
July 28, 2025 — Doptelet (avatrombopag) is a prescription medicine that helps the body make more platelets (cells that help stop bleeding). First approved in 2018 for adults, it is now also approved by the FDA for children aged 1 year or older with chronic immune thrombocytopenia (ITP) who haven’t gotten good responses from earlier treatments.
- FDA OKs New Steroid-Free Skin Cream for Hand Eczema
July 24, 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 8, 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 7, 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 19, 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 12, 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 11, 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 10, 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 30, 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 19, 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.