Featured News August FDA actions include Novo Nordisk’s Wegovy injection as the first GLP-1 for severe liver disease MASH, while Tonmya sublingual tablets are okayed for fibromyalgia. Ajovy is cleared for pediatric migraine, Repatha for additional cardiovascular uses, and Brinsupri and Papzimeos for serious respiratory conditions. Hernexeos gets accelerated approval in non-small cell lung cancer, Modeyso is cleared for a rare, mutated brain tumor while Dawnzera is a new option to prevent hereditary angioedema. Plus, KETARx (ketamine) is okayed for surgical pain management.
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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. - mNEXSPIKE (COVID-19 Vaccine, mRNA) Injection
Approval: August 27, 2025
Now Approved for: Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2
Press Release | Approval History
- Nuvaxovid (COVID-19 Vaccine, Adjuvanted) Injectable Suspension
Approval: August 27, 2025
Now Approved: 2025-2026 Formula
Press Release | Approval History
- Avtozma (tocilizumab-anoh) Injection
Approval: July 29, 2025
Now Approved for: Cytokine Release Syndrome
Press Release | Approval History
- Filspari (sparsentan) Tablets
Approval: August 27, 2025
Now Approved: REMS Modification
Press Release | Approval History
- Leqembi (lecanemab-irmb) Injection
Approval: August 29, 2025
Now Approved: Leqembi Iqlik Subcutaneous Injection
Press Release | Approval History
- Comirnaty (COVID-19 Vaccine, mRNA) Injection
Approval: August 27, 2025
Now Approved for: Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19
Press Release | Approval History
- Wegovy (semaglutide) Injection
Approval: August 15, 2025
Now Approved for: Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Press Release | Approval History
- Ajovy (fremanezumab-vfrm) Injection
Approval: August 5, 2025
Now Approved for: Preventive Treatment for Pediatric Episodic Migraine
Press Release | Approval History
- Repatha (evolocumab) Injection
Approval: August 21, 2025
Now Approved for: Adults at Increased Risk for Major Adverse Cardiovascular Events Due to Uncontrolled LDL-C
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. - Iron Sucrose Injection
50 mg elemental iron/2.5 mL (20 mg/mL), 100 mg elemental iron/5 mL (20 mg/mL) and 200 mg elemental iron/10 mL (20 mg/mL)
Approved: August 8, 2025 - International Medication Systems Ltd.; Sandoz Inc; Mylan Laboratories Limited
Treatment for: Iron Deficiency Anemia
Generic for:
Venofer
- Cangrelor for Injection
50 mg/vial
Approved: August 11, 2025 - Gland Pharma Limited
Treatment for: Percutaneous Coronary Intervention
Generic for:
Kengreal
- Liraglutide Injection
18 mg/3 mL (6 mg/mL)
Approved: August 27, 2025 - Teva Pharmaceutical Industries Limited
Treatment for: Weight Loss in Obesity
Generic for:
Saxenda
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Other Drug News - FDA Now Providing Daily Updates on Adverse Events
- Shingles Vaccine, Shingrix, Might Protect Against Heart Attack, Stroke
- Common Pain Meds, Acetaminophen and Ibuprofen, Could Be Contributing To Antibiotic Resistance
- GLP-1 Drugs Are Good For Climate Change, Heart Study Says
- Many Cancer Patients Say Doctors Aren't Honoring Their Treatment Desires
- FDA Suspends U.S. License of Chikungunya Vaccine
- Most Pain Patients Quit Medical Weed Within A Year, Study Says
- Roll Up Your Sleeve: Flu Shot Season is At Hand
- Omega-3s Might Protect Against Nearsightedness
- Nasal Spray Flu Vaccine, FluMist, Now Available for At-Home Use
- Acetaminophen Linked To Autism/ADHD, Evidence Review Argues
- FDA Approves Ketamine Product, KETARx, for Surgical Pain Management
- New Blood Pressure Guidelines Highlight Lifestyle Changes, Tailored Treatment
- New Means Found For Treating Blood Staph Infections with IV Dalbavancin
- Phone App, OTX-202, Reduces Suicide Among High-Risk Patients
- New Vaccine May Help Stop Deadly Pancreatic Cancers From Coming Back
- Chewable Dog Medication, Apoquel, Sends Two Cats Into Kidney Failure
- New Weight Loss Pill From Eli Lilly, Orforglipron, Shows Promise in Early Study
- Tamiflu Safe For Children, Study Concludes
- Fear Of Hair Loss Might Cause Some To Reject Cancer Treatment
- Dizzy, Heart Racing After You Stand? New Treatment Proposed
- Rezlidhia May Also Fight a Deadly Bone Marrow Disorder
- An Artificial Sweetener May Hamper Immunotherapy Cancer Treatment
- Do Millipedes Hold Key to Pain Relief, Parkinson's Treatment?
- Coming Soon: An At-Home Patch to Spot Skin Cancers?
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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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