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.
FDA Grants Fast Track Designation for Potential Bird Flu Vaccine
The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial of the vaccine was initiated in November 2024.
FDA Approves Generic Liraglutide for Type 2 Diabetes
As of April 2, 2025, liraglutide remained in shortage, with the drug first entering the FDA database on July 18, 2023.
FDA Approves Denosumab-Bnht as Biosimilar to Prolia, Xgeva
Denosumab-bnht (Conexxence, Bomyntra) became the third biosimilar in 2025 to be approved for denosumab (Prolia, Xgeva).
FDA Approves Gepotidacin for Uncomplicated UTI
The decision makes the therapy the first oral antibiotic treatment approved for uUTIs in over 20 years.
FDA Approves Vutrisiran For Adult Patients With ATTR-CM
The decision makes the RNAi therapeutic the only therapy approved by the FDA to treat ATTR-CM and hATTR-PN.
FDA Approves Losartan Potassium for Reduction in Risk of Stroke
The new approval is an oral suspension for patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy.
FDA Approves Omalizumab-Igec as First Interchangeable Biosimilar to Xolair
Omalizumab-igec is approved to treat moderate to severe persistent asthma in patients 6 years and older whose symptoms are not well controlled with inhaled corticosteroids.
FDA Grants Orphan Drug Designation to BIOX-101 for Intracerebral Hemorrhagic Stroke
Currently, there is a gap in treatment for this patient population and intracerebral hemorrhagic stroke is considered an orphan disease.
FDA Approves neffy for Treatmet of Type 1 Allergic Reactions, Anaphylaxis
The approval is the first significant innovation for the delivery of epinephrine for this population in more than 35 years, according to the company news release.
FDA Approves Denosumab-Bmwo as Biosimilar to Prolia, Xgeva
Denosumab-Bmwo is approved for all indications of the respective reference products, including osteoporosis and high-risk of fracture due to chemotherapy.
Depemokimab Demonstrates Significant Improvements in Rhinosinusitis with Nasal Polyps
GSK announced its ANCHOR-1 and ANCHOR-2 phase 3 trial results for depemokimab’s efficacy and safety in treating patients with chronic rhinosinusitis with nasal polyps.
FDA Approves House Dust Mite Allergy Therapy For Use in Young Children
The expanded indication now includes patients aged 5 through 11 years in addition to those aged 12 through 65 years.
FDA Grants Emapalumab-Izsg Priority Review for Macrophage Activation Syndrome
The drug is being investigated for adult and pediatric patients with hemophagocytic lymphohistiocytosis/macrophage activation syndrome in Still disease.
FDA Grants Emergency Authorization to Aptitude’s COVID, Flu Test
The next-gen molecular Metrix was given emergency use authorization for its ability to test for SARS-CoV-2 and influenza A and B viruses.
FDA Approves Updated Buprenorphine Label For Rapid Initiation Treatment
The updated label also includes alternative injection sites, such as the abdomen, thigh, buttock, or back of the upper arm.
