FDA News

The March 2025 approval for iptacopan marks the first for C3 glomerulopathy and is based on the APPEAR-C3G trial.

The approval for moderately to severely active Crohn disease marks the fourth indication for Johnson and Johnson's IL-23 inhibitor.

AstraZeneca announced eneboparatide normalized serum calcium with statistical significance at 24 weeks compared with placebo.

If approved, this indication targets the treatment of adult patients with heart failure with a left ventricular ejection fraction of ≥40%.

The submission is supported by results from the phase 3 DUPLEX Study and the phase 2 DUET Study in adult and pediatric patients with FSGS.

An audio recap of the top 5 stories in healthcare news from the week of 03/09-03/16

ATSN-201 gene therapy has previously received Rare Pediatric Disease and Orphan Drug designations from the regulatory agency.

The regulatory agency granted 510(k) clearance to Caristo Diagnostics' image analysis software to aid in coronary artery disease diagnosis.

With a new FDA goal date in June, ketamine is one step closer to receiving approval for anesthesia, sedation, pain, mental health, and neurological indications.

The regulatory agency accepted the BLA's filing and assigned a target action date of August 31, 2025.

Omalizumab-igec is approved in 2 formulations for the treatment of moderate to severe persistent asthma, CRSwNP, IgE-mediated food allergy, and CSU.

The FDA approved the sNDA for furosemide (Furoscix) to expand the indication to include treatment of edema in patients with CKD.

With this historic approval, revakinagene taroretcel (ENCELTO) becomes the first and only FDA-approved treatment for MacTel.

The FDA approval for epinephrine nasal spray 1 mg is indicated for type 1 allergic reactions in children 15 to 30 kg and 4 years or older.

The agency approved the first generic of the anticoagulant rivaroxaban to lower the risk of cardiovascular and thromboembolic events in adults with CAD and PAD.

Marking the first stroke medicine approved in nearly 30 years, the single five-second intravenous bolus provides faster administration than the standard of care.

The regulatory agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025.

Our top 5 headlines include an FDA approval, a pair of submissions, data from AAAAI 2025, and more!

This FDA News Month in Review provides a round-up of regulatory decisions from February 2025.

Teva and Medincell announced FDA acceptance of their sNDA for UZEDY, a risperidone extended-release injectable, to treat adults with bipolar I disorder.

On Feb. 26, 2025, Arcutis Biotherapeutics announced the FDA's acceptance of their sNDA for roflumilast cream 0.05% in AD for children aged 2 to 5 years.

The regulatory agency has set a PDUFA target action date of August 27, 2025, for the investigational gene therapy.

An audio recap of the top 5 stories in healthcare news from the week of 02/16 - 02/23.

Epioxa has been assigned a target action date of October 20, 2025, for the regulatory agency’s review of the NDA.

FDA approves expanded use of buprenorphine extended-release injection for opioid use disorder, adding new injection sites and reducing treatment induction time.