FDA News

The Fast Track Designation was granted to Biodexa Pharmaceuticals’ eRapa based on phase 2 data showing its safety and tolerability in adults with FAP.

Our top 5 headlines include a trial of gene-edited pig kidneys, a first-of-its-kind antibiotic approval, and new guidelines for migraine.

Emblaveo combines aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor.

Brensocatib, also a potential first-in-class DPP1 inhibitor, has a PDUFA date of August 12, 2025.

The FDA’s approval marks the second indication for Genentech's refillable ocular implant in addition to wet age-related macular degeneration.

Our top 5 headlines include approvals for a non-opioid pain reliever, the latest indication for semaglutide, positive phase 2 data in MASH, and more.

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

The FDA approval of suzetrigine, a non-opioid pain signal inhibitor, may help address the needs of patients with moderate-to-severe acute pain.

Axsome Therapeutics announced that the FDA approved the NDA for AXS-07 to treat acute migraine with or without aura on January 30, 2025.

Awarded to Roche, the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay will be the first 510(k) cleared test measuring Lp(a) in nanomoles per liter (nmol/L).

The FDA approved semaglutide to reduce the risk of kidney disease worsening, kidney failure, and death due to CVD in those with T2D and CKD.

The regulatory agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 14, 2025.

The FDA approved updated labeling for viloxazine ER capsules as an ADHD treatment, adding lactation data and details on serotonin 5-HT2C receptor activity.

This class 2 recall of almost 3000 First Aid Beauty brand face moisturizers resulted from deviation from Current Good Manufacturing Practice regulations.

The approval of Amneal Pharmaceuticals’ generic version of rifaximin 550 mg oral tablets is tentative due to the product’s involvement in litigation.

HCPLive spoke with Mattingly about esketamine’s recent FDA approval as a monotherapy for treatment-resistant depression which works within hours or 1 – 2 days.

The Breakthrough Therapy designation comes just months after positive phase 2 data for brelovitug were presented at AASLD The Liver Meeting in 2024.

The FDA approved esketamine (SPRAVATO) nasal spray as the first monotherapy for adults with TRD, showing rapid efficacy at 4 weeks.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 18, 2025.

Axatilimab in 9 mg and 22 mg vial sizes are expected to launch in early February for the treatment of chronic graft-versus-host disease.

The approval is based on data from the phase 3 VIVID-1 study and marks mirikizumab’s second approval in IBD, the first being ulcerative colitis in 2023.

Submission of the supplemental NDA was based on positive findings from the FINEARTS-HF trial investigating finerenone for heart failure with an LVEF ≥40%.

4D-150 shows promising efficacy and safety in DME as FDA greenlights Phase 3 trial for Biologics License Application submission.

After accepting the avacincaptad pegol sNDA on January 6, 2025, the FDA has set a target action date for February 26.

The designation follows positive topline data from the phase 2a trial of CNP-104 in PBC, which were presented at AASLD’s The Liver Meeting