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Manish Wadhwa, MD, discusses Implicity’s newest algorithm to improve the accuracy of implantable cardiac monitors in identifying arrhythmic episodes.

FDA-Cleared, AI-Assisted ECG Analyzer Algorithm Reduces False Positives in ICMs

The generic nasal spray is bioequivalent to Haleon's Flonase, indicated for nasal symptoms of allergic rhinitis.

FDA Approves Glenmark’s Generic Fluticasone Propionate Nasal Spray

The first-in-class D1 receptor antagonist earns Priority Review and Orphan Drug designation, with an FDA action date late in Q1 2027.

FDA Accepts NDA for Ecopipam in Pediatric Tourette Syndrome

The FDA accepted EIT Pharma’s lonafarnib NDA for chronic hepatitis D, supported primarily by the phase 3 D-LIVR trial.

Lonafarnib NDA Enters FDA Review for Chronic Hepatitis D

FDA grants volixibat Breakthrough Therapy and Orphan Drug status for PSC pruritus, but recommends an additional phase 3 trial before NDA.

FDA Grants Volixibat Breakthrough Therapy, Orphan Designations for PSC

Resilient Pharmaceuticals has resubmitted its MDMA-assisted therapy NDA for PTSD without a new phase 3 trial, MAPS reported.

MDMA-Assisted Therapy NDA Resubmitted to FDA for PTSD

Robert Wood, MD, of Johns Hopkins University explains what the July 31 exit means for peanut oral immunotherapy and omalizumab-assisted desensitization.

Palforzia Discontinuation Ends Only FDA-Approved Peanut OIT

Hematology in July 2026: FDA priority review for Agios' mitapivat in sickle cell disease, plus Orca-T's approval for GVHD-free survival.

3 Hematology Headlines You Missed in July 2026

The mRNA-based vaccine wins full approval for adults aged 50 to 64 years and accelerated approval for adults aged ≥ 65 years following unanimous VRBPAC backing.

mFLUSIVA Receives FDA Approval for Influenza in Adults 50 and Older

FDA approval is based on phase 3 FirstLight and RadiantLight trials, the first therapy to directly restore orexin signaling in adults with NT1.

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