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.
FDA Approves Chenodiol for Treatment of Cerebrotendinous Xanthomatosis
Ctexli is the first FDA-approved treatment for adults with cerebrotendinous xanthomatosis.
FDA Says Ozempic, Wegovy Shortage Resolved
Semaglutide has been in shortage since 2022 due to increased demand.
FDA Grants Breakthrough Therapy Designation to SkinTE for Wagner Grade 1 Diabetic Foot Ulcers
By 12 weeks, investigators report that SkinTE facilitated significantly more wound closures compared with the standard of care.
FDA Accepts New Drug Application for Vatiquinone to Treat Friedreich Ataxia
The FDA also granted priority review, with a Prescription Drug User Fee Act target action date of August 19, 2025.
FDA to Evaluate Lenacapavir for Prevention of HIV
A PDUFA target action date for the PrEP therapy has been set for June 19, 2025.
FDA Accepts sBLA for Dupilumab for Bullous Pemphigoid
Previously, dupilumab (Dupixent) received orphan drug designation for bullous pemphigoid.
FDA Approves Recombinant Chikungunya Vaccine, Vimkunya
The vaccine is the first virus-like particle single-dose vaccine for chikungunya for patients 12 years and older.
FDA Approves Denosumab-Dssb as Biosimilar for Prolia, Xgeva
Denosumab-dssb is approved as a 60 mg pre-filled syringe as a biosimilar for Prolia and 120 mg vial as a biosimilar for Xgeva.
FDA Approves MenABCWY Vaccine for Patients Ages 10 to 25 Years
The combination includes 2 previously approved vaccines to target the 5 major serogroups of Neisseria meningitidis.
FDA Grants Fast Track Designation to Cannabis Withdrawal Syndrome Therapy
A dose response is observed with the highest dose of the drug and mitigating withdrawal symptoms for patients with cannabis use disorder.
FDA Approves Risdiplam Tablet for Spinal Muscular Atrophy
The tablet formation of risdiplam (Evrysdi) demonstrates bioequivalence to the oral formulation of the drug.
FDA Grants Fast Track Designation to Amlenetug As Treatment for Multiple System Atrophy
The designation is based on the AMULET phase 2 trial, which was the first-in-human study of the drug.
FDA Grants Fast Track Designation to Troculeucel for Moderate Alzheimer Disease
Data has shown the investigational cell therapy is well-tolerated in patients and showed preliminary impacts on cognition.
FDA Grants ADI-001 Fast Track Designation as Treatment of Refractory Systemic Lupus Erythematosus
ADI-001 is an investigation allogeneic gamma delta chimeric antigen receptor T cell therapy that targets CD20 for the treatment of a variety of autoimmune diseases.
FDA Grants ABO-101 Orphan Drug, Rare Pediatric Disease Designations for PH1
Primary hyperoxaluria type 1 (PH1) is a rare genetic condition that affects the kidney, bladder, or urinary tract, and indicates high levels of oxalates in the urine.
FDA Approves Ranibizumab Injection for Diabetic Macular Edema
The therapy is now the first and only FDA-approved treatment that maintains vision with fewer treatments compared to standard-of-care injections.
FDA Approves Apomorphine for Treatment of Motor Fluctuations in Parkinson Disease
The drug will be made available in the second quarter of 2025.
