FDA Updates

The drug will be made available in the second quarter of 2025.

The approval makes Johnson and Johnson’s esketamine nasal spray the first and only monotherapy for the treatment of major depressive disorder in adult patients.

Using the DASH Rapid PCR System, providers can yield test results in under 1 minute of hands-on time.

Zepbound from Eli Lilly is the first and only prescription medicine approved by the FDA for adults with obstructive sleep apnea and obesity.

The patient’s symptoms gradually resolved after discontinuing fezolinetant therapy.

Vtama from Organon was previously approved in May 2022 to treat plaque psoriasis in adults.

Catch up on important FDA news from the week of December 2.

This approval marks the availability of the first near-complete stabilizer of transthyretin.

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

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.