FDA News

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.

Alpyn’s Investigational New Drug application’s clearance by the FDA for the new Zabalafin Hydrogel for atopic dermatitis follows positive phase 2a clinical findings.

Amneal Pharmaceuticals launched mesalamine 800 mg delayed-release tablets for UC and received FDA approval for various lenalidomide doses for blood cancers.

Pitolisant was evaluated for the supplemental indication in the phase 3 INTUNE study, which did not meet its primary outcome of reducing excessive daytime sleepiness.

Chemomab completed an end-of-phase 2 meeting with the FDA and has aligned on the design of a phase 3 registration study for nebokitug (CM-101) in PSC.

Alvotech and Teva expect the review to be completed in the fourth quarter of 2025.

The FDA decision to approve the supplemental biologics license application for dupilumab (Dupixent) follows recent pivotal clinical trial data assessing 106 patients.

Targeted Genomics’ GHR test uses NGS to detect genetic variants in genomic DNA isolated from at-home collected saliva samples.