FDA Updates

A PDUFA target action date for the PrEP therapy has been set for June 19, 2025.

Previously, dupilumab (Dupixent) received orphan drug designation for bullous pemphigoid.

The vaccine is the first virus-like particle single-dose vaccine for chikungunya for patients 12 years and older.

Denosumab-dssb is approved as a 60 mg pre-filled syringe as a biosimilar for Prolia and 120 mg vial as a biosimilar for Xgeva.

The combination includes 2 previously approved vaccines to target the 5 major serogroups of Neisseria meningitidis.

A dose response is observed with the highest dose of the drug and mitigating withdrawal symptoms for patients with cannabis use disorder.

The tablet formation of risdiplam (Evrysdi) demonstrates bioequivalence to the oral formulation of the drug.

The designation is based on the AMULET phase 2 trial, which was the first-in-human study of the drug.

Data has shown the investigational cell therapy is well-tolerated in patients and showed preliminary impacts on cognition.

Primary hyperoxaluria type 1 (PH1) is a rare genetic condition that affects the kidney, bladder, or urinary tract, and indicates high levels of oxalates in the urine.

The therapy is now the first and only FDA-approved treatment that maintains vision with fewer treatments compared to standard-of-care injections.

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.

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.