Latest Drugs News
- FDA Approves New Long-Term Treatment for Myasthenia Gravis
May 2, 2025 — The FDA approves Imaavy, a groundbreaking treatment for generalized myasthenia gravis (gMG), offering symptom relief and reduced autoantibody levels in adults and children over 12.
- FDA OKs New Drug for Rare Head and Neck Cancer
April 25, 2025 — The FDA has approved a new drug for adults with a rare type of head and neck cancer known as non-keratinizing nasopharyngeal carcinoma (NPC).
- FDA Issues Warning About Counterfeit Ozempic
April 14, 2025 — The FDA and the maker of the popular diabetes and weight loss drug Ozempic are warning people not to use counterfeit semaglutide 1.0 milligrams — the Ozempic injection — found in the U.S. drug supply chain.
- FDA Approves New Treatment for Serious Kidney Disorder
April 3, 2025 — The FDA has approved Vanrafia (atrasentan), a once-daily pill that reduces proteinuria in adults with immunoglobulin A nephropathy (IgAN), offering new hope for slowing kidney damage.
- FDA Green-Lights First New Antibiotic for UTIs in Nearly 30 Years
March 26, 2025 — The FDA has approved Blujepa, a groundbreaking new antibiotic for treating uncomplicated urinary tract infections in women, marking the first new class of UTI medication in nearly three decades.
- FDA OKs First Myasthenia Gravis Treatment for Children
March 11, 2025 — The FDA approved Soliris for children aged 6 and older with generalized myasthenia gravis (gMG), offering new hope for managing this autoimmune neuromuscular disorder.
- FDA OKs Nasal Spray for Severe Allergic Reactions in Kids
March 6, 2025 — The FDA has approved Neffy, a needle-free nasal spray, for children aged 4 and up, providing fast and effective treatment for severe allergic reactions and anaphylaxis.
- FDA Approves New Treatment for Stroke
March 4, 2025 — The FDA has approved TNKase, a new, fast-acting stroke treatment that dissolves blood clots more efficiently, marking a significant advancement in stroke therapy and clot-busting technology.
- FDA OKs First Fast-Acting Insulin Biosimilar for Diabetes
February 20, 2025 — The FDA has approved Merilog, a new fast-acting insulin biosimilar for managing blood sugar in people with diabetes, marking the first such biosimilar to receive federal approval.
- FDA Approves New Drug for Rare Joint Tumor
February 18, 2025 — The FDA has approved vimseltinib, a new oral drug for a rare, noncancerous tumor of the joints known as tenosynovial giant cell tumor (TGCT). It is intended for adults with symptomatic TGCT when surgery could worsen their condition.
- FDA OKs Triple Combo for Advanced Large B-Cell Lymphoma
February 13, 2025 — The FDA has approved a new three-drug combination to treat certain types of an aggressive blood cancer called large B-cell lymphoma (LBCL).
- FDA OKs New Antibiotic Combo for Serious Abdominal Infections
February 10, 2025 — The FDA has approved a new antibiotic combination called Emblaveo to treat serious stomach infections in adults who have few or no other treatment options.
- FDA OKs Implantable Treatment for Diabetic Macular Edema
February 6, 2025 — The FDA has approved a new implantable treatment for adults with diabetic macular edema (DME) after studies showed that it could help maintain vision with as few as two treatments per year.
- FDA Approves New Non-Opioid Pain Treatment
January 31, 2025 — The FDA has approved suzetrigine (Journavx), a new non-opioid oral drug for acute pain in adults – the first new class of non-opioid pain medicine approved in over 20 years.
- FDA OKs Ozempic for Kidney Disease in Diabetes Patients
January 29, 2025 — The FDA has approved Novo Nordisk's diabetes drug Ozempic to help reduce the risk of worsening kidney disease, kidney failure, and heart-related death in adults with type 2 diabetes and chronic kidney disease (CKD).
- FDA Approves Drug for Hard-to-Treat Breast Cancer
January 28, 2025 — The FDA has approved fam-trastuzumab deruxtecan, marketed under the brand name Enhertu, as a new treatment for certain types of advanced breast cancer that have spread or cannot be removed with surgery.
- FDA Approves New Prep Regimen for Bone Marrow Transplant
January 23, 2025 — The FDA has approved a new treatment, Grafapex, to help people get ready for a bone marrow transplant.
- FDA Approves Zepbound for Obstructive Sleep Apnea
December 23, 2024 — he FDA has approved the first prescription drug, Zepbound, for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
- FDA OKs First Treatment for Familial Chylomicronemia Syndrome
December 20, 2024 — The FDA has approved olezarsen, a new drug that helps reduce high triglyceride levels in adults with a rare genetic condition called familial chylomicronemia syndrome (FCS).
- FDA Approves New Drug for Kids With Severe Immune Disease
December 20, 2024 — The FDA has approved remestemcel-L, a new treatment for children age 2 months or older with steroid-refractory acute graft-versus-host disease (SR-aGVHD), a major complication of donor bone marrow transplantation.
- FDA Approves New Drug for Advanced Lung Cancer
December 19, 2024 — The FDA has approved a new drug called ensartinib for adults with a type of lung cancer called ALK-positive non-small-cell lung cancer (NSCLC).
- FDA Approves Nemluvio for Atopic Dermatitis
December 17, 2024 — The FDA has approved Nemluvio for treating moderate to severe atopic dermatitis, a type of eczema, in people aged 12 or older.
- FDA Approves Drug for Rare Adrenal Gland Disorder
December 17, 2024 — The FDA has approved crinecerfont, marketed under the brand name Crenessity, a first-in-class oral drug for treating classic congenital adrenal hyperplasia (CAH), a rare genetic condition present from birth.
- FDA Approves New Drug for Advanced Skin Cancer
December 16, 2024 — The FDA has approved cosibelimab (marketed under the brand name Unloxcyt), a new drug for adults with advanced cutaneous squamous cell carcinoma (CSCC), a type of skin cancer.
- FDA Approves Drug for Aggressive Small-Cell Lung Cancer
December 9, 2024 — The FDA has approved the drug durvalumab for adults with limited-stage small-cell lung cancer (LS-SCLC) whose disease hasn’t gotten worse after getting platinum-based chemo and radiation at the same time.
- FDA Approves New Drug for Lung and Pancreatic Cancers
December 5, 2024 — The FDA has granted accelerated approval to zenocutuzumab, a new drug for adults with advanced non-small-cell lung cancer (NSCLC) or pancreatic cancer.
- FDA Approves New SVT Drug for Critical Care Use
December 2, 2024 — The FDA has approved Rapiblyk, a new drug to treat irregular heartbeats in critically ill hospitalized patients with severe supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter.
- FDA Approves New Drug for Life-Threatening Heart Condition
November 25, 2024 — The FDA has approved Attruby, a new oral treatment that helps reduce heart-related deaths and hospital visits among adults with transthyretin amyloid cardiomyopathy, or ATTR-CM.
- FDA Approves Bimzelx for Hidradenitis Suppurativa
November 21, 2024 — The FDA has approved Bimzelx for adults with hidradenitis suppurativa (HS) or acne inversa, a type of chronic skin inflammation that affects about 1 in 100 people.
- First-in-Class Leukemia Treatment Approved by FDA
November 19, 2024 — The FDA has approved a new drug called revumenib that can be taken orally to treat acute leukemia in patients 1 year or older. The drug will be marketed under the brand name Revuforj.
- First Brain-Injected Gene Therapy Approved by FDA
November 18, 2024 — The FDA has granted fast-track approval for a groundbreaking gene therapy indicated for a rare genetic disorder called aromatic L-amino acid decarboxylase (AADC) deficiency.
- FDA Approves New Immunotherapy for Aggressive Leukemia
November 11, 2024 — The FDA has approved a new treatment, Aucatzyl, for a type of aggressive blood cancer called B-cell acute lymphoblastic leukemia (B-cell ALL). This treatment, a CAR T-cell immunotherapy, works by using the patient’s modified immune cells to target and kill cancer cells. Aucatzyl is designed to last longer and cause fewer side effects than similar therapies.
- New Rosacea Treatment Option Approved by the FDA
November 7, 2024 — The FDA has approved an antibiotic called minocycline for the treatment of rosacea in adults. The drug, which is taken orally, will be sold under the brand name Emrosi.
- New FDA Warning Added to Popular Weight Loss Drugs
November 6, 2024 — Labels for drugs like Mounjaro, Ozempic, and Saxenda now warn against aspiration risk during surgery.
- FDA Fast-Tracks Asciminib for New Chronic Leukemia Patients
October 31, 2024 — The FDA has granted accelerated approval to asciminib as a first-line treatment for adults newly diagnosed with Philadelphia chromosome–positive chronic myeloid leukemia, a rare type of blood cancer.
- FDA OKs New Drug for Urinary Tract Infections
October 28, 2024 — The FDA has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.
- New Hemophilia Drug Helps Prevent Bleeding Episodes
October 14, 2024 — The FDA has approved a new preventive treatment for people with certain types of hemophilia that can reduce bleeding episodes, sometimes down to just a few per year.
- New Drug Approved for Common Type of Breast Cancer Recurrence
October 14, 2024 — A new breast cancer drug has received quick federal approval after a clinical trial showed it could more than double the time before a common type of breast cancer recurrence worsens.
- Dupixent Gets FDA Approval for COPD
October 2, 2024 — The label expansion provides a new option for the hundreds of thousands of Americans with inadequately controlled COPD.
- FDA OKs Second Treatment for Rare, Deadly Genetic Disorder
September 26, 2024 — Within days of approving the first treatment for a rare genetic disorder, the FDA has approved another treatment for the same condition.
- FDA OKs First Treatment for Rare, Deadly Genetic Disorder
September 24, 2024 — Miplyffa treats Niemann-Pick disease type C, which progressively impacts the abilities to speak, swallow, and walk or move independently.
- FDA Approves First At-Home Nasal Flu Vaccine
September 23, 2024 — The FDA has OK'd FluMist, a nasal spray flu vaccine that you can give and get at home – no health care provider needed. It’s the first flu vaccine of its kind, offering a simple, convenient, needle-free option that its maker hopes will improve access and uptake.
- Popular Weight Loss Drugs Raise Risk of More Stomach Trouble
October 5, 2023 — People taking popular medications like Ozempic, Wegovy, and Rybelsus for weight loss are at higher risk of potentially serious stomach and intestinal issues, compared to people taking a weight loss drug approved in 2014, a large study reveals.
- New Depression Drug Avoids Unfortunate Side Effects of Others
September 29, 2023 — The drug, Exxua, will stand out on the market because studies show it does not cause side effects like sexual dysfunction or weight gain.
- FDA Adds Warning of Intestinal Blockages to Ozempic Label
September 28, 2023 — The FDA has received more than 8,500 reports of gastrointestinal issues among people taking medications like Ozempic and Wegovy, the latter of which is approved for weight loss.
- Popular OTC Decongestants Don’t Really Work, FDA Says
September 13, 2023 — Many products, including Sudafed PE, contain phenylephrine, which an FDA committee said is ineffective.
- 3D-Printed Meds Customize the Exact Dose for Sick Children
September 7, 2023 — Researchers hope to enhance pediatric care by printing tablets in child-friendly doses, shapes, and flavors.
- Drugs Advertised on TV Aren't Better Than Existing Options: Study
January 18, 2023 — Most drugs advertised on television don't work better than existing alternatives, a new analysis shows. And manufacturers spend more on advertising for those less beneficial drugs, compared to ones that work better.