FDA Updates

FDA approves Biktarvy for HIV treatment in patients not virologically suppressed, enhancing options for those restarting antiretroviral therapy.

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.

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.

The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026.

The therapy is now the first and only oral on-demand treatment option for the condition.

This approval offers pediatric patients and caregivers the first subcutaneous option that can be administered at home.

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.

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 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.

Pharmacists can substitute ustekinumab with the biosimilar at the pharmacy level, depending on their state laws.

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.