FDA Updates

FDA approves etripamil nasal spray, offering a rapid, self-administered solution for adults with paroxysmal supraventricular tachycardia (PSVT).

The agency’s findings spur promises of significant change to the development and recommendations surrounding various immunizations.

Regeneron Pharmaceuticals’ newest drug will be the first and only approved flexible treatment option for retinal vein occlusion.

The FDA approves denosumab biosimilars Osvyrti and Jubereq, expanding treatment options for osteoporosis and bone-related conditions.

FDA approves lumateperone as an adjunct therapy for major depressive disorder, offering new treatment options for this indication.

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 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 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.

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.