Featured News

In June, the FDA cleared key agents in the antiviral, oncology and autoimmune sectors. Dupixent is the first targeted treatment for skin condition bullous pemphigoid, while Mavyret is the first treatment for acute hepatitis C virus. Other key agents are Enflonsia for infant respiratory syncytial virus (RSV) prevention, Andembry in hereditary angioedema and Yeztugo, a long-lasting HIV PrEP. New oncology approvals include Monjuvi, Ibtrozi and Keytruda. Plus, added dosage forms for Brukinsa and Benlysta provide new administration options.

New Drug Approvals

The following drugs have recently been approved by the FDA.

• Harliku (nitisinone) Tablets

  Date of Approval: June 19, 2025
  Treatment for: Alkaptonuria
  Press Release | Approval History

• Yeztugo (lenacapavir) Tablets and Injection

  Date of Approval: June 18, 2025
  Treatment for: Pre-Exposure Prophylaxis of HIV
  Press Release | Approval History

• Andembry (garadacimab-gxii) Injection

  Date of Approval: June 16, 2025
  Treatment for: Hereditary Angioedema
  Press Release | Approval History

• Arynta (lisdexamfetamine dimesylate) Oral Solution

  Date of Approval: June 16, 2025
  Treatment for: ADHD, Binge Eating Disorder
  Press Release | Approval History

• Zusduri (mitomycin) for Intravesical Solution

  Date of Approval: June 12, 2025
  Treatment for: Bladder Cancer
  Press Release | Approval History

• Ibtrozi (taletrectinib) Capsules

  Date of Approval: June 11, 2025
  Treatment for: Non Small Cell Lung Cancer
  Press Release | Approval History

• Enflonsia (clesrovimab-cfor) Injection

  Date of Approval: June 9, 2025
  Treatment for: RSV Vaccination and Immunization
  Press Release | Approval History

• Widaplik (amlodipine, indapamide and telmisartan) Tablets

  Date of Approval: June 5, 2025
  Treatment for: High Blood Pressure
  Press Release | Approval History

• Xifyrm (meloxicam) Injection

  Date of Approval: June 5, 2025
  Treatment for: Pain
  Press Release | Approval History

New Indications and Dosage Forms

Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.

• Datroway (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection

  Approval: June 23, 2025
  Now Approved for: EGFR-Mutated Non-Small Cell Lung Cancer
  Press Release | Approval History

• Steqeyma (ustekinumab-stba) Injection

  Approval: June 12, 2025
  Now Approved: Additional Presentation Expanding Dosing Options for Pediatric Patients
  Press Release | Approval History

• mRESVIA (respiratory syncytial virus vaccine, mRNA) Injection

  Approval: June 12, 2025
  Now Approved for: Adults Aged 18–59 at Increased Risk for RSV Disease
  Press Release | Approval History

• Xenoview (xenon Xe 129 hyperpolarized) for Oral Inhalation

  Approval: May 30, 2025
  Now Approved for: Pediatric Patients Aged Six Years and Older
  Press Release | Approval History

• Monjuvi (tafasitamab-cxix) for Injection

  Approval: June 18, 2025
  Now Approved for: Follicular Lymphoma
  Press Release | Approval History

• Brukinsa (zanubrutinib) Capsules and Tablets

  Approval: June 10, 2025
  Now Approved: Tablet Formulation
  Press Release | Approval History

• Nubeqa (darolutamide) Tablets

  Approval: June 3, 2025
  Now Approved: In Combination with ADT for Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
  Press Release | Approval History

• Gamifant (emapalumab-lzsg) Injection

  Approval: June 28, 2025
  Now Approved for: Macrophage Activation Syndrome in Still's Disease
  Press Release | Approval History

• Mavyret (glecaprevir and pibrentasvir) Tablets and Oral Pellets

  Approval: June 10, 2025
  Now Approved for: Acute Hepatitis C Virus Infection
  Press Release | Approval History

• Endari (L-glutamine) Oral Powder

  Approval: June 18, 2025
  Now Approved: Label Enhancements Including Administration With or Without Food
  Press Release | Approval History

• Dupixent (dupilumab) Injection

  Approval: June 18, 2025
  Now Approved for: Bullous Pemphigoid
  Press Release | Approval History

• Keytruda (pembrolizumab) for Injection

  Approval: June 12, 2025
  Now Approved for: Head & Neck Squamous Cell Carcinoma as Neoadjuvant Treatment, Continued as Adjuvant Treatment Combined With Radiotherapy
  Press Release | Approval History

• Vizamyl (flutemetamol F 18) Injection

  Approval: June 23, 2025
  Now Approved: Expanded Indications Enabling More Precise Care for Alzheimer’s Patients
  Press Release | Approval History

• Benlysta (belimumab) Injection

  Approval: June 20, 2025
  Now Approved: Autoinjector for Children with Active Lupus Nephritis
  Press Release | Approval History

• Gammagard Liquid (immune globulin infusion (human)) Solution

  Approval: June 27, 2025
  Now Approved: Gammagard Liquid ERC
  Press Release | Approval History

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.

• Angiotensin II Acetate Intravenous Solution
  2.5mg (base)/mL
  Approved: June 3, 2025 - Gland Pharma Limited
  Treatment for: Shock
  Generic for: Giapreza
• Sitagliptin Phosphate and Metformin Hydrochloride Extended Release Tablets
  50 mg (base)/500 mg, 50 mg (base)/1000 mg and 100 mg (base)/1000 mg
  Approved: June 4, 2025 - Endo Operations Ltd.
  Treatment for: Type 2 Diabetes
  Generic for: Janumet XR
• Rivaroxaban for Oral Suspension
  1 mg/mL
  Approved: June 26, 2025 - Alkem Laboratories Limited
  Treatment for: Treatment and Prevention of Blood Clots
  Generic for: Xarelto for Oral Suspension

Other Drug News

• 'Pill-On-A-String' Could Revolutionize Testing For Throat Cancer
• FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T Cell Immunotherapies
• Many Kids Unnecessarily Hospitalized Following Allergic Reactions
• Monthly Obesity Shot, MariTide, Shows Big Weight Loss in Trial
• Nearly 30 People in England Get Rare Illness After Botox
• Stem Cell Treatment May Free Some With Type 1 Diabetes From Insulin
• Studies Address Muscle Loss Caused By GLP-1 Drugs, such as Ozempic and Zepbound
• Cystic Fibrosis: Symptoms, Treatments, Causes & More
• Blood Test Might Predict Rapid Decline in Alzheimer's Patients
• HIV Drug, Lamivudine, Potentially Effective Against Diabetic Eye Disease
• Fecal Transplant Potential First-Line Treatment For C. Difficile Infection
• Braces Top Best Therapies For Knee Arthritis
• Psychedelics Can Help Cancer Patients Battling Depression
• Real-World Results For GLP-1 Drugs Underwhelm, Study Says
• Statins Appear Effective In Treating Sepsis
• Combo Drug Treatment More Effective For Kidney Disease in Type 2 Diabetics
• CPAP Or Zepbound? Patients, Doctors Debate Sleep Apnea Treatment
• There's A Better Clot-Preventing Option Than Aspirin, Researchers Say
• Immunotherapy Effective Against Stomach Cancer
• More U.S. Teens Are Now Taking Wegovy for Weight Loss

FDA MedWatch Alerts

• FDA Requires Expanded Labeling About Weight Loss Risk in Patients Younger Than 6 Years Taking Extended-Release Stimulants for ADHD
• Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
• FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination
• Drug Safety Communication: FDA Investigating Deaths Due to Acute Liver Failure in Non-Ambulatory Duchenne Muscular Dystrophy Patients Following Elevidys
• FDA Adds Warning About Serious Risk of Heat-Related Complications With Antinausea Patch Transderm Scōp (scopolamine transdermal system)
• Medtech Products Inc. Issues Nationwide Recall of Little Remedies Honey Cough Syrup Due to Microbial Contamination
• Church & Dwight Issues Voluntary Nationwide Recall of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs Due to Microbial Contamination
• Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, Due to Microbial Contamination

FDA Consumer Updates

• FDA 101: Product Recalls
• Tianeptine Products Linked to Serious Harm, Overdoses, Death
• Is Rinsing Your Sinuses With Neti Pots Safe?
• Where and How to Dispose of Unused Medicines
• A Fresh Take on What "Healthy" Means on Food Packages

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