FDA News and Regulatory Updates

FDA clears a dissolvable sildenafil oral film for erectile dysfunction, offering discreet, water-free dosing and strong phase 3 results ahead of 2026 launch.

The FDA delays approval of Anaphylm, a sublingual epinephrine film for anaphylaxis, citing administration and human factors study deficiencies.

Centanafadine's FDA priority review signals potential innovation in ADHD treatment, offering a new nonstimulant option for diverse patient needs.

The FDA updates Afrezza's prescribing information, enhancing dosing guidance for adults switching from injected insulin to improve glycemic control.

ACON Laboratories launches the first FDA-cleared at-home test for RSV, influenza, and COVID-19, enhancing respiratory symptom management for families.

FDA requests removal of suicidal ideation warnings from GLP-1 receptor agonist labeling after a comprehensive review found no increased risk.

Your daily dose of the clinical news you may have missed.

FDA identifies deficiencies in Anaphylm's NDA, impacting labeling discussions, while review continues for this innovative treatment for severe allergic reactions.

FDA prioritizes review of Tzield for young children with stage 2 type 1 diabetes, potentially delaying disease onset and improving patient outcomes.

The FDA has accepted a supplemental NDA for AXS-05 for agitation associated with Alzheimer disease and granted Priority Review, with a PDUFA action date of April 30, 2026.

Take a quick look back at developments this year with our higlights of acceleration of DMTs, particularly focusing on anti-amyloid antibodies and novel oral agents.

The FDA approved once-daily oral semaglutide 25 mg for chronic weight management and long-term weight maintenance in adults with obesity or overweight, based on data from the OASIS clinical trial program.

Abbott's Volt PFA System gains FDA approval, offering a new minimally invasive treatment for atrial fibrillation, enhancing patient care options.

Phase 3 LIBerate data showed sustained LDL-C reductions of 60% or more in high-risk patients and 50% or more in HeFH, with once-monthly self-administration.

Approval of the novel long-acting mAb was based on the phase 3 SWIFT-1 and SWIFT-2 trials, which showed steep reductions in annualized asthma exacerbations requiring ED or inpatient care.

The mobile-based program targets cognitive processes underlying attention and is intended for use alongside medication, therapy, or education.

Phase 3 results showed durable conversion benefits with a favorable safety profile, informing real-world management of acute PSVT outside of emergency settings.

Zolifodacin is a single-dose oral treatment option for uncomplicated urogenital gonorrhea and one of the first new classes of drugs for the disease in 20 years.

Flow Therapeutics announced approval of its Flow-100 tDCS therapy for depression, which could expand access to non-pharmacologic care and will be available in the US in H2 2026.

Your daily dose of the clinical news you may have missed.

Insulet enhances the Omnipod® 5 system with new glucose targets and algorithms, improving insulin delivery for diabetes management.

Your daily dose of the clinical news you may have missed.

New safety and biomarker results from MK-2214 and MK-1167 advance Merck’s dual approach to Alzheimer therapy.

Former CBER chief calls claims "misrepresentation." ID experts Offit and Osterholm criticize timing ahead of CDC advisory committee meeting next week.

Otsuka seeks FDA approval for centanafadine, a novel ADHD treatment showing significant efficacy and safety in pivotal trials for all age groups.