Featured News New July FDA approvals and updates span multiple therapeutic areas, ranging from rare metabolic disorders to eczema. Approvals include oral Ekterly for hereditary angioedema (HAE), topical Anzupgo for chronic hand eczema, and Zegfrovy tablet for non-small cell lung cancers. Regeneron’s Lynozyfic has received accelerated approval for multiple myeloma, Kirsty is an interchangeable biosimilar to NovoLog, and Sephience gains a green light in rare phenylketonuria. Other label updates include notable changes for Skytrofa, Doptelet, Kisunla and Empaveli.
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New Drug Approvals The following drugs have recently been approved by the FDA.
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New Indications and Dosage Forms Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. - Alhemo (concizumab-mtci) Injection
Approval: July 31, 2025 Now Approved for: Hemophilia A or B Without Inhibitors Press Release | Approval History
- Kisunla (donanemab-azbt) Injection
Approval: July 1, 2025 Now Approved: New Dosing in Early Symptomatic Alzheimer's Disease Press Release | Approval History
- Spikevax (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection
Approval: July 9, 2025 Now Approved for: Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease Press Release | Approval History
- Leqvio (inclisiran) Injection
Approval: July 31, 2025 Now Approved: First-Line Use in Hypercholesterolemia Press Release | Approval History
- Skytrofa (lonapegsomatropin-tcgd) Lyophilized Powder for Injection
Approval: July 25, 2025 Now Approved for: Adults with Growth Hormone Deficiency Press Release | Approval History
- Kerendia (finerenone) Tablets
Approval: July 11, 2025 Now Approved for: Heart Failure with Left Ventricular Ejection Fraction (LVEF) ≥40% Press Release | Approval History
- Empaveli (pegcetacoplan) Injection
Approval: July 28, 2025 Now Approved for: C3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis Press Release | Approval History
- Doptelet (avatrombopag) Tablets and Oral Granules
Approval: July 24, 2025 Now Approved: Pediatric Formulation and Indication Press Release | Approval History
- Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) Tablets
Approval: July 30, 2025 Now Approved for: People With HIV Who Are Treatment Experienced And Restarting Antiretroviral Treatment Press Release | Approval History
- Shingrix (zoster vaccine recombinant, adjuvanted) Injection
Approval: July 16, 2025 Now Approved: Prefilled Syringe Presentation Press Release | Approval History
- Spritam (levetiracetam) Tablets for for Oral Suspension
Approval: June 27, 2025 Now Approved for: Nasogastric and Gastrostomy Tube Administration Press Release | Approval History
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First-Time Generic Approvals First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace. - Perampanel Oral Suspension
0.5 mg/mL
Approved: July 11, 2025 - MSN Laboratories Private Limited
Treatment for: Seizures
Generic for:
Fycompa Oral Suspension
- Tazarotene Topical Lotion
0.045%
Approved: July 29, 2025 - Padagis Israel Pharmaceuticals Ltd.
Treatment for: Acne Vulgaris
Generic for:
Arazlo
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Other Drug News - Women Less Likely to Get Certain MS Meds Than Men
- Autoantibodies Influence Cancer Response To Immunotherapy, Study Says
- U.S. to Remove Mercury Preservative From Flu Jabs
- African Psychedelic, Ibogaine, Might Help Combat Vets Recover From Traumatic Brain Injury
- Vitamin D Might Offer Protection Against COVID-19
- Pregnant Women Turning To Safer Antiseizure Drugs
- Some Newer Antiseizure Meds Safer During Pregnancy
- Experts Recommend Healthy Lifestyle Changes Alongside GLP-1 Drug Use
- Tuberculosis Is Back on the Rise: What To Know About Symptoms and Treatment
- Nicotine Pouch Ingestions Surge Among Young Children
- GLP-1 Drugs Increase Risk Of Acid Reflux, GERD
- Menopause Hormone Therapy Boosts GLP-1 Drug Effectiveness, Researchers Say
- Popular Chronic Pain Med, Gabapentin, Linked To Dementia Risk
- Clash Of Drugs Impedes Lung Cancer Treatment, Lowers Survival
- CDC Now Recommends RSV Vaccine for Some Adults 50+
- Psoriasis 101: Causes, Symptoms and Treatments, Explained
- Many Older Adults Taking Daily Aspirin Despite Tighter Guidelines
- Schools Should Be Prepared For These Three Medical Emergencies
- FDA Removes REMS Requirements for Embryofetal Toxicity Risk From All Endothelin Receptor Antagonist Medicines
- FDA Will Now Require Labeling of ADHD Medication to Indicate Weight Loss Risk
- Medicaid, Medicare Don't Adequately Cover Addiction Treatment, Study Says
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This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party websites. The Editorial Team, Drugs.com
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