BRIMOCHOL PF, a combination eye drop for presbyopia, achieved all primary and secondary endpoints in its most recent trial.
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Aldeyra announces intention to resubmit NDA with new trial data in mid-year 2025.
The approval indicates Novartis's atrasentan (Vanrafia) for proteinuria reduction in primary IgA nephropathy.
The FDA granted fast-track status to Biogen’s BIIB080, a tau-targeting therapy for Alzheimer Disease, which is now being evaluated in the global phase 2 CELIA study.
March highlights groundbreaking advancements in ophthalmology, including FDA approvals for innovative treatments and alarming findings on pediatric eye health post-COVID.
The first quarter of 2025 saw approvals in diabetes, depression, kidney disease, and pain, among others. Read more about high-impact approvals of Q1 now.
The FDA accepted an sNDA for pegcetacoplan for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis.
Ragni discussed unique advantages fitusiran offers over other approved therapies for hemophilia A or B.
The Biologics License Application submission for sibeprenlimab is supported by results from the phase 2 ENVISION and phase 3 VISIONARY clinical trials.
An audio recap of the top 5 stories in healthcare news from the week of 03/23-03/2.
Data from the phase 3 ATLAS trial supported Qfitlia's BLA, with the latest data presented at December’s ASH meeting.
Treprostinil (YUTREPIA) was previously granted tentative approval on August 16, 2024.
Announced on March 28, 2025, the FDA's CRL to Milestone Pharmaceuticals cites CMC issues, but no issues with safety or efficacy data.
The FDA approval of diazoxide choline extended-release tablets (Vykat XR) was announced on March 26, 2025.
A Q2 2025 preview spotlighting 10 FDA decisions to watch, including upcoming PDUFAs for dupilumab, pz-cel, ketamine, clesrovimab, and more!
The approval is based on data from the phase 3 EAGLE-2 and EAGLE-3 trials.
The IND submission for VERVE-102 was supported by interim data from the dose-escalation portion of the ongoing Heart-2 Phase 1b clinical trial.
An audio recap of the top 5 stories in healthcare news from the week of 03/16-03/23.
The approval expands the indication for vutrisiran, which becomes the first therapeutic approved by the FDA for the treatment of ATTR-CM.
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
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