FDA Updates

The FDA releases its updated recommendations and scientific considerations for the demonstration of safety and efficacy among biosimilars and their reference products.

The approval includes a single and once monthly maintenance injection compared with 2 100 mg/1 mL injections.

Tezspire gains FDA approval as the first biologic for chronic rhinosinusitis with nasal polyps, offering improved patient outcomes.

FDA approves oral semaglutide for reducing cardiovascular risks in high-risk type 2 diabetes patients, enhancing treatment options and outcomes.

The FDA expands Yuflyma's approval to treat hidradenitis suppurativa and uveitis in pediatric patients, enhancing treatment options for chronic conditions.

The FDA approves the Insti HIV Self Test, enabling rapid, accurate results in just one minute, enhancing access to HIV testing nationwide.

The biosimilar is also approved for indications of Eylea, including neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic retinopathy.

As the sixth approval for roflumilast in less than 4 years, the cream is expected to impact the 1.8 million children who have reported atopic dermatitis.

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

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.

Liraglutide is the first glucagon-like peptide-1 to have a generic equivalent for both type 2 diabetes and obesity indications.

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.