FDA Updates

Prior to the government shutdown, the FDA approved a generic version of mifeprisone without a public announcement.

This is the first Bruton tyrosine kinase inhibitor FDA approved for chronic spontaneous urticaria.

This marks the first and only IL-23 approval for these indications in pediatric populations.

Bumetanide nasal spray is available in 0.5 mg, which is an alternative to traditional oral and intravenous formulations for outpatient therapies.

FDA approves ruxolitinib cream for children with atopic dermatitis, offering a new nonsteroidal treatment option for better symptom management.

The FDA also grants the biosimilar provisional interchangeability designation, making the drug substitutable at the pharmacy level.

Medtronic’s diabetes management technology reached 2 milestones upon FDA approval, allowing integration of continuous glucose monitoring for patients with type 1 and type 2 diabetes.

The FDA approves denosumab-nxxp (Bildyos and Bilprevda), enhancing access to vital bone health treatments for osteoporosis and cancer-related conditions.

FDA approves Leqembi's subcutaneous formulation, enhancing accessibility for Alzheimer treatment and paving the way for future combination therapies.

The approved vaccines include Novavax’s Nuvaxovid and Moderna’s Spikevax and mNexspike.

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.

The FDA removes the prior requirement for a patient who is already diagnosed with a cardiovascular disease.

Cyclobenzaprine HCl sublingual tablets (Tonmya) are the first new FDA-approved therapy for fibromyalgia in over 15 years.

FDA approves Wegovy for treating metabolic dysfunction–associated steatohepatitis, marking a breakthrough in liver health management and patient care.

Fremanezumab-vfrm (Ajovy) receives FDA approval for the prevention of episodic migraine for patients aged 6 to 17 years.

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 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.