FDA Updates

The addition of a 10 mg oxycodone hydrochloride tablet improves dosing flexibility and precision.

The FDA has approved just the second treatment for uncomplicated urinary tract infections (UTIs) in the last 2 decades.

Abrysvo is the only RSV vaccine approved for use in this age group.

Gepotidacin is a first-in-class oral antibiotic with a novel mechanism of action.

On June 26, 2024, the FDA approved ensifentrine (Ohtuvayre) for the treatment of COPD.

The FDA approved ceftobiprole medocaril sodium for injection (Zevtera) in April 2024.

Check out important updates from the FDA for the week of October 7.

Marstacimab-hncq is the first non-factor and once-weekly treatment available for patients with hemophilia B and promises to reduce the burden of care.

The approval is supported by results from phase 3 multi-regional clinical trials conducted in patients with plaque psoriasis.

Check out important updates from the FDA for the week of September 30.

Check out these important FDA updates from the month of September 2024.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways.

The approval of xanomeline and trospium chloride (Cobenfy) from Bristol Myers Squibb represents a “transformative moment in the treatment of schizophrenia.”

The approval comes shortly after the FDA approved arimoclomol from Zevra Therapeutics to treat neurological manifestations of the disease in combination with miglustat.

Initiatives such as media campaigns and legislative rulings by the agencies have likely contributed to the decline.

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.

Nymalize is an effective alternative to capsule extraction for adult patients with subarachnoid hemorrhage who are unable to swallow capsules.

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).