FDA Approves First Generic GLP-1 Liraglutide for Weight Loss
Liraglutide is the first glucagon-like peptide-1 to have a generic equivalent for both type 2 diabetes and obesity indications.
FDA Approves COVID-19 Vaccines for Patients 65 Years and Older
The approved vaccines include Novavax’s Nuvaxovid and Moderna’s Spikevax and mNexspike.
FDA Approves Updated 2025-2026 COVID-19 Vaccine for Patients 65 Years and Older
The approval covers Pfizer and BioNTech’s LP.8.1-adapted monovalent COVID-19 vaccine, which is also indicated for patients aged 5 to 64 with at least 1 underlying condition.
FDA Expands Approval of Evolocumab to Include Patients at Increased Risk of MACE
The FDA removes the prior requirement for a patient who is already diagnosed with a cardiovascular disease.
FDA Approves Cyclobenzaprine Sublingual Tablets for Treatment of Fibromyalgia
Cyclobenzaprine HCl sublingual tablets (Tonmya) are the first new FDA-approved therapy for fibromyalgia in over 15 years.
FDA Approves Semaglutide to Treat MASH With Moderate to Advanced Fibrosis
FDA approves Wegovy for treating metabolic dysfunction–associated steatohepatitis, marking a breakthrough in liver health management and patient care.
FDA Approves Fremanezumab as First Anti-CGRP Drug for Prevention of Pediatric Episodic Migraine
Fremanezumab-vfrm (Ajovy) receives FDA approval for the prevention of episodic migraine for patients aged 6 to 17 years.
FDA Approves Biktarvy for Patients With HIV Previously Treated With Antiretroviral Therapy
FDA approves Biktarvy for HIV treatment in patients not virologically suppressed, enhancing options for those restarting antiretroviral therapy.
FDA Approves Concizumab as Daily Prophylaxis for Hemophilia A and B
Many treatments for hemophilia A and B are administered via intravenous infusions, so the approval offers a subcutaneous injection for the treatment for patients 12 years and older.
FDA Approves Finerenone for Heart Failure With Left Ventricular Ejection Fraction
The approval is based on the FINEARTS-HF (NCT04435626), showing that the drug achieved a 16% relative risk reduction of cardiovascular death and total heart failure events.
FDA to Evaluate Merck’s Doravirine, Islatravir Regimen for HIV-1
The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026.
FDA Approves Sebetralstat for Hereditary Angioedema
The therapy is now the first and only oral on-demand treatment option for the condition.
FDA Approves Belimumab Autoinjection for Patients 5 and Older With Active Lupus Nephritis
This approval offers pediatric patients and caregivers the first subcutaneous option that can be administered at home.
FDA Approves Dupilumab for Treatment of Bullous Pemphigoid
Bullous pemphigoid is a rare skin condition that causes large blisters filled with fluids that typically occur near skin creases, such as the upper thighs and armpits.
FDA Approves Nitisinone for Treatment of Alkaptonuria
Alkaptonuria affects approximately 1 in 250,000 to 1 million people in the United States.
FDA Approves New Moderna COVID-19 Vaccine for Older Adults, High-Risk Patients
The new approval is in line with recommendations that suggest booster vaccination for older adults and patients aged 12 to 64 with at least 1 or more underlying risk factors.
FDA Approves Acoltremon Ophthalmic Solution for Dry Eye Disease
The new approval is for a first-in-class TRPM8 receptor agonist to stimulate corneal sensory nerves to increase natural tear production.
FDA Approves Hydrocortisone Oral Solution for Adrenocortical Insufficiency
The replacement therapy is indicated for patients 5 years and older, marking the first approval for an oral solution form of hydrocortisone.
FDA Grants Interchangeability Designation to Adalimumab-Bwwd for Humira
This designation follows Hadlima’s low-concentration prefilled syringes and single-dose vials, which were designated in June 2024.
FDA Approves Ustekinumab-Hmny as Biosimilar to Stelara
Ustekinumab is a medication used to treat and manage inflammatory conditions, including psoriasis, psoriatic arthritis, and inflammatory bowel disease.
FDA Approves Roflumilast Foam For Plaque Psoriasis of Scalp, Body
The supplemental new drug application for roflumilast (Zoryve) is approved for adult and pediatric patients 12 years and older.
FDA Approves Mepolizumab for Treatment of COPD Exacerbations
Approval comes from positive results in the MATINEE and METREX phase III trials, with data showing a significant reduction in annual rates of COPD exacerbations among patients.
FDA Will Make Importing Prescription Drugs From Canada Easier for States
Importing prescription drugs from Canada has been met with criticism, such as weakening the pharmaceutical supply chain and posing increased risks to patient safety.
FDA Grants Interchangeability Designation to Ustekinumab-Aauz for Stelara
Pharmacists can substitute ustekinumab with the biosimilar at the pharmacy level, depending on their state laws.
FDA Approves Nuvaxovid for the Prevention of COVID-19
Novavax’s COVID-19 vaccine has been available in the US under emergency use authorization since July 2022.
FDA Approves Dihydroergotamine as Auto Injectable for Migraine Treatment
Dihydroergotamine (Brekiya) is an acute treatment to help relieve migraine attacks, and it can come in nasal sprays, injections, and intravenous infusions.
FDA Approves Dupilumab for Treatment of Chronic Spontaneous Urticaria
The approval is based on 2 phase 3 studies demonstrating reductions in itch severity and urticaria activity as a composite of itch and hives at 24 weeks.
FDA Approves Diazepam Nasal Spray for Treatment of Seizure Clusters in Pediatric Patients
The drug is approved for the short-term treatment of acute repetitive seizures, also known as seizure clusters, which differ from a patient’s normal seizure pattern.
FDA Grants Yuflyma Interchangeability Designation for Humira
The FDA approved adalimumab-aaty in May 2023 for 8 indications, including rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis.
FDA Approves Subcutaneous Vyvgart Hytrulo for Generalized Myasthenia Gravis
The drug is also approved for adults with chronic inflammatory demyelinating polyneuropathy.
