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Topical Gene Therapy FDA-Approved for Severe Skin Disease, Dystrophic Epidermolysis Bullosa

PLOS: DNA Science

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done. Primary investigator M.

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FDA approves Abbott’s rapid portable COVID-19 test

The Pharma Data

.” This follows the FDA granting Emergency Use Authorization back in March to Abbott’s ID NOW rapid molecular test that can provide results in 30 minutes and can be used in doctor’s office labs and nursing homes. . The new test is different as it uses a companion mobile app for iPhone and Android to quickly display the results.

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DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

The Pharma Data

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

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Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults

The Pharma Data

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.

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First-in-human clinical trial for a vaccine to treat opioid use.

The Pharma Data

Because of its selectivity for oxycodone, the vaccine will not interfere with FDA-approved medications, including methadone, buprenorphine, naltrexone and naloxone, potentially offering a long-lasting, safe and cost-effective alternative that is complementary to standard medical intervention for opioid use disorders.

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Spectral Medical Announces Report on Clinical Implementation of SAMI Amid COVID-19 Published in the Journal of Blood Purification

The Pharma Data

The paper goes on to state, “The results from the nurse questionnaire, as well as the successful deployment of the SAMI in our institution during the pandemic with only 3-hour virtual training support that operating the SAMI is simple and safe. ” About Spectral and Dialco. Spectral is a Phase III company seeking U.S.

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2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

Roche will present data on the increased use of home nursing capabilities in the Phase III GRADUATE studies of gantenerumab during the COVID-19 pandemic, which enabled home-bound trial participants to continue dosing to maintain medicine exposure. Alzheimer’s Disease (AD). P1: Aging and Dementia: Biomarkers.