Remove FDA Approval Remove Nurses Remove Treatment
article thumbnail

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.

article thumbnail

The Long Road to End Tuberculosis

Codon

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. These challenges have led to strategies such as directly observed therapy (DOT), in which nurses or physicians monitor patients to ensure they take their medicine every day.

Vaccine 92
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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. If an allergic reaction occurs, treatment with DALVANCE should be discontinued. AbbVie (NYSE: ABBV) today announced that the U.S.

article thumbnail

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. The initiation of treatment requires no loading dose or oral supplementation.

article thumbnail

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

The Pharma Data

Marco Pravetoni, PhD, a leading expert of biologics for the treatment of substance use disorders and developer of the vaccine candidate, is an associate professor of pharmacology and medicine at the University of Minnesota Medical School. The study plans to enroll up to 45 volunteers.

article thumbnail

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., It remains under review by the FDA. It remains under review by the FDA.

article thumbnail

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

The Pharma Data

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. The Company plans to initiate a Phase 2 trial within the next several months. “We