Kathryn Wighton

New York

Web Editor at WebMD

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Articles

FDA Clears First At-Home HPV Test

1 week ago | conexiant.com | Kathryn Wighton

The FDA has cleared for marketing the first at-home test for cervical cancer screening, according to the manufacturer. The test offers an alternative to clinician-administered Pap tests performed in-office. Teal Health reported that the FDA’s decision was based on a study involving more than 600 women, demonstrating non-inferiority of self-collected samples compared with clinician-collected specimens.
FDA Approves Low-Dose Chlorthalidone Tablet

1 week ago | conexiant.com | Kathryn Wighton

Chlorthalidone, a thiazide-like diuretic, is recognized in the 2017 American College of Cardiology/American Heart Association guideline as the preferred diuretic for hypertension management, based on its extended half-life and demonstrated cardiovascular outcome benefits.
FDA Approves TAVR Platform for Asymptomatic AS

1 week ago | conexiant.com | Kathryn Wighton

Among patients with asymptomatic severe aortic stenosis, just over a quarter of those who underwent early transcatheter aortic valve replacement experienced death, stroke, or unplanned cardiovascular hospitalization, compared with nearly half who were managed with clinical surveillance at a median follow-up of 3.8 years.
Ustekinumab Biosimilar Receives Interchangeability Approval

1 week ago | conexiant.com | Kathryn Wighton

Ustekinumab-aekn (Selarsdi) is now approved for all indications of the reference product, including moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients aged 6 years and older, as well as moderately to severely active Crohn’s disease and ulcerative colitis in adult patients. Interchangeability applies to all approved formulations, including subcutaneous and intravenous presentations.
FDA Monthly Round-up: Key April Updates

1 week ago | conexiant.com | Kathryn Wighton

From the first targeted therapy for chronic spontaneous urticaria and a new treatment for immunoglobulin G4–related disease, to the first oral Janus kinase inhibitor for giant cell arteritis and a 6-month continuous glucose monitor, April’s U.S. Food and Drug Administration approvals highlighted progress in immunology, endocrinology, rheumatology, and more. Here's a comprehensive overview of the month’s key decisions.
FDA Approves Intranasal DHE for Acute Migraine Relief

2 weeks ago | conexiant.com | Kathryn Wighton

Atzumi is an FDA-approved dihydroergotamine nasal powder for the acute treatment of migraine, delivered via a proprietary intranasal system that has been shown to achieve rapid and sustained plasma concentrations. Developed by Satsuma Pharmaceuticals, a subsidiary of Shin Nippon Biomedical Laboratories, Ltd., Atzumi is the first dihydroergotamine (DHE) nasal powder to be approved in the U.S. It is also the only product to utilize the Simple MucoAdhesive Release Technology platform.
FDA Approves FcRn Blocker for Broad gMG Use

2 weeks ago | conexiant.com | Kathryn Wighton

Nipocalimab-aahu has been approved to treat both adult and pediatric patients with generalized myasthenia gravis who are acetylcholine receptor– or muscle-specific kinase antibody–positive.
New Oral Option Approved for GCA

2 weeks ago | conexiant.com | Kathryn Wighton

The U.S. Food and Drug Administration approval of oral upadacitinib (Rinvoq) was supported by data from the phase III SELECT–giant cell arteritis trial, in which 46.4% of patients receiving the drug with a 26-week corticosteroid taper achieved sustained remission from week 12 to week 52 compared with 29.0% of those receiving placebo with a 52-week taper regimen (P = .002). The safety profile observed during the 52-week placebo-controlled period was generally consistent with previous indications.
FDA Approves Penpulimab-kcqx for NPC

3 weeks ago | conexiant.com | Kathryn Wighton

Penpulimab-kcqx extended progression-free survival to 9.6 months compared to 7.0 months with chemotherapy alone in patients with recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma.
FDA Warns of Topical Finasteride Risks

3 weeks ago | conexiant.com | Kathryn Wighton

Compounded topical finasteride products have been linked to persistent adverse effects—including sexual dysfunction and mood disturbances—even after discontinuation, according to recent FDA reports. The FDA has issued a safety alert concerning compounded topical finasteride products, citing reports of adverse events and highlighting the lack of FDA approval for these formulations.