FDA Updates

Zevra Therapeutics said it expects the therapy to be commercially available in the United States in 8 to 12 weeks.

The vaccine will be made available via third-party online pharmacies.

Check out important updates from the FDA for the week of September 16.

The Eversense 365 is the world’s first long-term CGM that provides 1 year of use and should be available by the fourth quarter of 2024.

This approval offers an additional treatment option for a disease that can commonly return.

The approval was based on data from the phase 3 MANDARA trial, where the therapy met the primary endpoint of proportion of patients in remission at weeks 36 and 48.

Lebrikizumab-lbks is a targeted treatment that addresses the root cause of atopic dermatitis; by reducing inflammation throughout the body, it can help alleviate the dry, itchy, and irritated skin that often characterizes the condition.

Over 30 million American adults experience some hearing loss, yet only one-fifth benefit from hearing aids; the FDA’s approval will expand access to the technology for the patient population.

Check out important updates from the FDA for the week of August 9.

Check out important updates from the FDA for the week of September 2.

DaylightRX from Big Health is a digital formulation of cognitive behavioral therapy and is available by prescription only.

Embecta’s new patch pump offers a larger insulin reservoir to better accommodate for the needs of patients with type 2 diabetes (T2D).

Bezisterim acts on inflammatory signaling pathways and may be a viable treatment option for post–COVID-19 condition, or long COVID.

The protein-based vaccine includes a monovalent component corresponding to the Omicron variant JN.1 strain.

Emergent BioSolutions has announced that it will donate 50,000 doses of ACAM2000 for potential deployment across affected areas in Central Africa.

Checkout these important FDA updates from the month of August 2024.

The device was previously cleared for use in children and adults with type 1 diabetes.

Check out important updates from the FDA for the week of August 19.

Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.

FDA approval of Amneal Pharmaceuticals' propofol injectable emulsion single-dose vials aims to address the drug’s history of chronic supply issues.

Final approval of the therapy may occur after expiration of the 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025.

First To Know Syphilis Tests are expected to be available at major national retailers and online in late 2024.

Check out important updates from the FDA for the week of August 12.

Medtronic also announced it has entered a global partnership with Abbott in an effort to expand CGM device options for patients living with diabetes.

Two phase 3 trials evaluating nemolizumab found that 41% of patients treated with the therapy achieved at least a 4-point reduction in itch intensity at week 16.

Ascendis Pharma said it is currently completing manufacturing of commercial product, which it anticipates will be available in the US in the first quarter of 2025.

The agency said it could not approve the new drug application based on the submitted data and requested an additional Phase 3 trial to “further study the safety and efficacy” of the therapy.

The epinephrine nasal spray from ARS Pharmaceuticals has become the first and only needle-free epinephrine alternative and the first new delivery method for epinephrine in over 3 decades.