Kathryn Wighton

New York

Web Editor at WebMD

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Articles

FDA Clears Tablet for Cholestatic Pruritus

1 week ago | conexiant.com | Kathryn Wighton

A new tablet formulation of maralixibat could offer an alternative to the oral solution, with once-daily dosing among patients with Alagille syndrome and twice-daily dosing among those with progressive familial intrahepatic cholestasis. The formulation is intended to treat those who may benefit from a solid-dose option.
New Self-Injection Option for gMG, CIDP

1 week ago | conexiant.com | Kathryn Wighton

The FDA has approved a prefilled syringe formulation of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous self-injection in adult patients with generalized myasthenia gravis who are anti–acetylcholine receptor antibody positive, as well as in adult patients with chronic inflammatory demyelinating polyneuropathy. This formulation offers an additional administration option alongside intravenous infusion and subcutaneous injection via vial.
FDA Clears Longest Lasting CGM

1 week ago | conexiant.com | Kathryn Wighton

The U.S. Food and Drug Administration has cleared a novel continuous glucose monitoring system known as Dexcom G7 15 Day for use in patients aged 18 years and older with diabetes. The updated continuous glucose monitoring (CGM) system offers up to 15.5 days of wear, making it the longest lasting wearable CGM system currently cleared in the United States.
FDA Clears Stapler for Single-Port Surgery

2 weeks ago | conexiant.com | Kathryn Wighton

Intuitive's SP SureForm 45 stapler was cleared by the U.S. Food and Drug Administration for use with the da Vinci SP surgical system in thoracic, colorectal, and urologic procedures. The clearance introduces the first stapler specifically designed for single-port robotic-assisted surgery. The SP SureForm 45 incorporates SmartFire technology, which continuously monitors tissue compression prior to and during staple firing, according to a press release from Intuitive.
Dual Immunotherapy Approved for Advanced CRC

2 weeks ago | conexiant.com | Kathryn Wighton

Patients with microsatellite instability–high or mismatch repair–deficient colorectal cancer treated with nivolumab plus ipilimumab had a median progression-free survival that was not reached, compared with 5.8 months for patients treated with chemotherapy, according to a recent press release.
First FDA-Approved IgG4-RD Treatment

2 weeks ago | conexiant.com | Kathryn Wighton

In the MITIGATE trial, inebilizumab-cdon (Uplizna) reduced the risk of immunoglobulin G4–related disease flares by 87% compared with placebo in adult patients. Based on data from the study, the FDA approved inebilizumab as the first and only treatment for adults with immunoglobulin G4–related disease (IgG4-RD), a chronic, immune-mediated fibroinflammatory condition affecting multiple organ systems.
New Option for IgA Nephropathy Management

3 weeks ago | conexiant.com | Kathryn Wighton

In a phase III trial, atrasentan reduced proteinuria by 36.1% in adults with immunoglobulin A nephropathy. Effects were observed as early as week 6 and were sustained through week 36. The FDA has granted accelerated approval to atrasentan, a selective endothelin A receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for rapid disease progression, Novartis reported in a press release today.
FDA Approves Automated Latent TB Test

3 weeks ago | conexiant.com | Kathryn Wighton

The newly U.S. Food and Drug Administration–approved automated latent tuberculosis test (Auto-Pure 2400 platform) was capable of completing the first day of T-SPOT.TB testing in under 3.5 hours and required only one midrun user interaction, according to the manufacturer.
FDA Monthly Round-Up: Key March Updates

3 weeks ago | conexiant.com | Kathryn Wighton

From the first interchangeable Xolair biosimilar and a needle-free epinephrine spray for children, to the first liquid losartan formulation and an over-the-counter multi-STI home test, March’s FDA approvals reflect a focus on improving accessibility, administration, and therapeutic innovation across several specialties. Here is a comprehensive overview of the month's key FDA decisions.
FDA Approves Freeze-Dried Jynneos Vaccine

3 weeks ago | conexiant.com | Kathryn Wighton

The U.S. Food and Drug Administration has approved a freeze-dried formulation of the Jynneos smallpox and mpox vaccine (live, nonreplicating) for the prevention of smallpox and mpox in adults aged 18 years or older.