Zolgensma is an adeno-associated virus vector-based gene therapy.
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Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris.
The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
The American College of Allergy, Asthma and Immunology (ACAAI) has issued a statement regarding the use of corticosteroids for patients with allergies and asthma.
The FDA has approved the use of Dupixent (dupilumab; Sanofi and Regeneron) to treat moderate-to-severe atopic dermatitis in adolescent patients 12–17 years old.
Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). The sBLA included data from two phase 3 randomized, double-blind, placebo-controlled trials (SINUS-24…
The FDA has approved a prefilled pen formulation of Dupixent (dupilumab; Sanofi and Regeneron), providing another option for administering the treatment.
A study in the American Journal of Respiratory and Critical Care Medicine reports that older asthma patients, particularly those treated with inhaled corticosteroids, appear to be at an increased risk for treatment failure compared to those under the age of 30.
The primary endpoint was met with 75% of the benralizumab group reducing their OCS doses compared to 25% in the placebo group. Additionally, 52% of the benralizumab group who had optimized baseline OCS doses of ≤12.5mg/d were able to completely stop OCS use.
AstraZeneca announced that two pivotal Phase 3 registrational trials for benralizumab achieved their primary endpoint, demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.