FDA Updates

Alkaptonuria affects approximately 1 in 250,000 to 1 million people in the United States.

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.

The new approval is for a first-in-class TRPM8 receptor agonist to stimulate corneal sensory nerves to increase natural tear production.

The replacement therapy is indicated for patients 5 years and older, marking the first approval for an oral solution form of hydrocortisone.

This designation follows Hadlima’s low-concentration prefilled syringes and single-dose vials, which were designated in June 2024.

Ustekinumab is a medication used to treat and manage inflammatory conditions, including psoriasis, psoriatic arthritis, and inflammatory bowel disease.

The supplemental new drug application for roflumilast (Zoryve) is approved for adult and pediatric patients 12 years and older.

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.

Importing prescription drugs from Canada has been met with criticism, such as weakening the pharmaceutical supply chain and posing increased risks to patient safety.

Novavax’s COVID-19 vaccine has been available in the US under emergency use authorization since July 2022.

Dihydroergotamine (Brekiya) is an acute treatment to help relieve migraine attacks, and it can come in nasal sprays, injections, and intravenous infusions.

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.

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.

The FDA approved adalimumab-aaty in May 2023 for 8 indications, including rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis.

The drug is also approved for adults with chronic inflammatory demyelinating polyneuropathy.

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.

As of April 2, 2025, liraglutide remained in shortage, with the drug first entering the FDA database on July 18, 2023.

Denosumab-bnht (Conexxence, Bomyntra) became the third biosimilar in 2025 to be approved for denosumab (Prolia, Xgeva).

The decision makes the therapy the first oral antibiotic treatment approved for uUTIs in over 20 years.

The decision makes the RNAi therapeutic the only therapy approved by the FDA to treat ATTR-CM and hATTR-PN.

The new approval is an oral suspension for patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy.

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.

Currently, there is a gap in treatment for this patient population and intracerebral hemorrhagic stroke is considered an orphan disease.

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.

Denosumab-Bmwo is approved for all indications of the respective reference products, including osteoporosis and high-risk of fracture due to chemotherapy.

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.

The expanded indication now includes patients aged 5 through 11 years in addition to those aged 12 through 65 years.

The drug is being investigated for adult and pediatric patients with hemophagocytic lymphohistiocytosis/macrophage activation syndrome in Still disease.