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Novaliq’s dry eye disease therapy receives US FDA approval

Pharmaceutical Technology

CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% Findings from the long-term extension ESSENCE-2 OLE trial showed that CyclASol’s effect was maintained and improved for most endpoints over a treatment period of 52 weeks.

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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Top 30 New Medical Devices of 2024

XTalks

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

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Filsuvez Topical Gel Gets FDA Approval for Epidermolysis Bullosa

XTalks

Filsuvez topical gel is a sterile botanical drug product designed for topical use, containing birch triterpenes within an oil base. For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. Specifically, 41.3 percent observed in the control gel arm. percent of cases.

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Ycanth (Cantharidin) Revolutionizes Molluscum Contagiosum Treatment with FDA Approval

XTalks

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. Both trials demonstrated no severe adverse reactions.

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GSK’s Dostarlimab Wins FDA Approval for dMMR Endometrial Cancer

XTalks

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

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Novo’s obesity drug has serious warnings and barriers to overcome

World of DTC Marketing

The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware. Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate, and suicidal behavior or thinking.

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