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    Susquehanna Raises Penn Entertainment Inc. (PENN) Price Target. – Yahoo Finance

    Susquehanna Raises Price Target for Penn Entertainment Inc. (PENN)

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    Susquehanna Raises Penn Entertainment Inc. (PENN) Price Target. – Yahoo Finance

    Susquehanna Raises Price Target for Penn Entertainment Inc. (PENN)

    George Lopez is coming to Spokane – KXLY.com

    George Lopez is coming to Spokane – KXLY.com

    Netflix unveils Dallas immersive venue for fans of hit shows like ‘Squid Game,’ ‘Stranger Things’ – Houston Chronicle

    Step Inside Netflix’s New Dallas Immersive Experience Featuring Hits Like ‘Squid Game’ and ‘Stranger Things

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    Wheel of Fortune’ Amputee Breaks Incredible ‘Curse’ to Win $60,000!

    North Star Sports & Entertainment Network: Coming soon – KTTC News

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    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

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    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

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FDA Gives Nod to Berdazimer Gel for Molluscum Contagiosum

January 7, 2024
in Health
FDA Gives Nod to Berdazimer Gel for Molluscum Contagiosum
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On January 5, the Food and Drug Administration (FDA) approved berdazimer gel 10.3% for the treatment of molluscum contagiosum (MC) in adults and children aged 1 year or older.

Approval of berdazimer, a topical nitric oxide–releasing agent, was based largely on a 12-week pivotal phase 3 trial known as B-SIMPLE4, in which 891 patients with a mean age of 6.6 years (range, 0.9-47.5 years) were randomly assigned to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily. At 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% of those in the vehicle group (P <.001>

Only 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events in both groups were application-site pain and erythema, and most of these were mild or moderate. 

According to a press release announcing the approval from Ligand Pharmaceuticals, which acquired berdazimer topical gel from Novan in September 2023, the development makes berdazimer topical gel 10.3% the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home; outside of a physician’s office; or outside of other medical settings to treat MC. Nitric oxide has been shown to have antiviral effects, although the mechanism of action of berdazimer for treating molluscum “is unknown,” the company said in the release. 

The drug will be marketed under the name Zelsuvmi and is expected to be available in the second half of 2024.

On July 21, 2023, topical cantharidin became the first approved treatment of MC for adults and pediatric patients aged 2 years or older, with the FDA approval of a drug-device combination (Ycanth) that contains a formulation of cantharidin solution 0.7% and is administered by healthcare professionals. 

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Medscape – https://www.medscape.com/viewarticle/fda-gives-nod-berdazimer-gel-molluscum-contagiosum-2024a10000fp

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