FDA Updates

The agency assigned prademagene zamikeracel a PDUFA target action date of April 29, 2025.

Check out these important FDA updates from the week of November 4.

The drug is also approved to treat schizophrenia and bipolar depression.

“Emrosi has potential to become the best-in-class oral medication to treat the condition,” said the CEO of Journey Medical.

The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.

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

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.

The therapy’s Prescription Drug User Fee Act date has been set for July 26, 2025.

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.