Featured News October FDA approvals include AbbVie’s Vyalev for advanced Parkinson disease, Astellas Pharma’s Vyloy for advanced gastric and GEJ cancer, and Pfizer’s Hympavzi for patients with hemophilia A or B without inhibitors. Orlynvah is a new oral UTI drug, plus a new single-dose injection for Bimzelx is cleared. Roche’s oral Itovebi is approved in breast cancer, and Imuldosa - the 5th biosimilar to Stelara - is accepted. Other new uses include those for Botox Cosmetic, Lumryz, Opdivo and Abrysvo.
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New Drug Approvals The following drugs have recently been approved by the FDA. - Orlynvah (sulopenem etzadroxil and probenecid) Tablets
Date of Approval: October 25, 2024
Treatment for: Urinary Tract Infection
Press Release | Approval History
- Vyloy (zolbetuximab-clzb) Injection
Date of Approval: October 18, 2024
Treatment for: Gastric Cancer
Press Release | Approval History
- Vyalev (foscarbidopa and foslevodopa) Injection
Date of Approval: October 16, 2024
Treatment for: Parkinson's Disease
Press Release | Approval History
- Hympavzi (marstacimab-hncq) Injection
Date of Approval: October 11, 2024
Treatment for: Hemophilia A, Hemophilia B
Press Release | Approval History
- Itovebi (inavolisib) Tablets
Date of Approval: October 10, 2024
Treatment for: Breast Cancer
Press Release | Approval History
- Imuldosa (ustekinumab-srlf) Injection
Date of Approval: October 10, 2024
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis
Press Release | Approval History
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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. - Selarsdi (ustekinumab-aekn) Injection
Approval: October 18, 2024
Now Approved: Additional Presentation and New Indications
Press Release | Approval History
- Bimzelx (bimekizumab-bkzx) Injection
Approval: October 11, 2024
Now Approved: 320 mg Single-Injection Device
Press Release | Approval History
- Abrysvo (respiratory syncytial virus vaccine) Injection
Approval: October 22, 2024
Now Approved for: Adults Aged 18 to 59 at Increased Risk for Lower Respiratory Tract Disease Caused by RSV
Press Release | Approval History
- Lumryz (sodium oxybate) Granules for Extended-Release Oral Suspension
Approval: October 16, 2024
Now Approved for: Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with Narcolepsy
Press Release | Approval History
- Jylamvo (methotrexate) Oral Solution
Approval: October 29, 2024
Now Approved for: Pediatric Patients with Acute Lymphoblastic Leukemia (ALL) and Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Press Release | Approval History
- Scemblix (asciminib) Tablets
Approval: October 29, 2024
Now Approved: Accelerated Approved in Newly Diagnosed CML
Press Release | Approval History
- RoxyBond (oxycodone hydrochloride) Tablets
Approval: October 29, 2024
Now Approved: Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology
Press Release | Approval History
- Ameluz (aminolevulinic acid) Gel
Approval: October 4, 2024
Now Approved: Maximum Dosage of Up to Three Tubes in One Treatment
Press Release | Approval History
- Opdivo (nivolumab) Injection
Approval: October 3, 2024
Now Approved: Perioperative Regimen for Non-Small Cell Lung Cancer
Press Release | Approval History
- Botox Cosmetic (onabotulinumtoxinA) for Injection
Approval: October 18, 2024
Now Approved for: Platysma Bands
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. - Minocycline Hydrochloride Injection
100 mg (base)/vial
Approved: October 24, 2024 - Nexus Pharmaceuticals, Inc.
Treatment for: Bacterial Infections
Generic for:
Minocin Injection
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Other Drug News - Costs for MS, Parkinson's and Alzheimer's Meds Keep Rising
- Autism Diagnoses Rising Among U.S. Children, Adults
- Once Again, Tuberculosis Becomes World's Top Infectious Disease Killer
- How AI Might Help Men Fighting Prostate Cancer
- New Hope Against a Rare, Aggressive Form of Thyroid Cancer
- Ozempic Curbs Kidney Disease in Obese People Without Diabetes
- What You Need to Know About FluMist, the Nasal Flu Vaccine
- Weight-Loss Surgeries Decline 25% as More Americans Turn to GLP-1 Meds
- Ozempic, Wegovy Might Help Lower Alzheimer's Risk in People With Diabetes
- Naloxone Implant Might Prevent Opioid Overdose
- Aerobic Exercise May Ease 'Brain Fog' of Breast Cancer Chemo
- Fatal Opioid-Meth Overdoses Have Fallen in U.S. by More Than a Third
- Biden Proposes That Insurers Cover Over-the-Counter Birth Control
- Real-World Study Confirms RSV Vaccine's, Arexvy and Abrysvo, Protective Power for Seniors
- New Drug Regimen Extends Survival for Cervical Cancer Patients
- What's the Best Clot-Buster Med After Stroke?
- More Kids Having Seizures After Swallowing Rx Painkillers, Diphenhydramine, Synthetic Pot
- FDA Says Compounding Pharmacies Can Keep Making Weight-Loss Med Tirzepatide, for Now
- Hope for New Test, Treatment for Endometriosis
- About 6% of U.S. Adults Have ADHD, Drug Shortages Are Affecting Treatment
- Only 1 in 5 Large Companies' Health Plans Cover New Weight-Loss Meds, Wegovy, Zepbound, for Employees
- Were FDA's 'Black Box' Warnings on Antidepressants a Mistake? Youth Suicides Rose Afterwards
- Epinephrine: Tips to the 'EpiPen' Ingredient and How It Treats Anaphylaxis
- U.S. Overdose Deaths Drop 10% in Early Data
- Water Fluoridation May Be Less Beneficial Than in Past, Review Finds
- Mpox Vaccine's Protection Wanes Within 1 Year; Boosters Needed
- This Season's Flu Vaccine Cuts Risk of Hospitalization by Almost 35%
- Scientists Get Closer to Stopping Macular Degeneration
- Drug Industry Taking Bigger Role in Clinical Cancer Trials
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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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