The designation was based on data from the Phase 2b PATHWAY trial that evaluated 3 doses of tezepelumab as add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids/long-acting β-agonist with or without oral corticosteroids and additional asthma controllers vs placebo.
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Diffuse, persistent, pruritic maculopapular rash developed 10 days after tocilizumab treatment
Patients with flares more likely to have inpatient, emergency department visits
Zolgensma is an adeno-associated virus vector-based gene therapy.
There were also significant differences between the groups in concomitant oral corticosteroid use (43.1 vs. 34.8% in the stable treatment and DT groups, respectively) and CRP level (1.9±2.5 vs. 1.1±1.3 respectively).
Currently, COPD guidelines recommend that patients with acute exacerbations be treated with systemic corticosteroids for 7-14 days, however, an updated review suggests that corticosteroid treatment of a shorter duration may be as effective as conventional longer-duration therapy.
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.
A panel of expert advisors to the U.S. Food and Drug Administration voted overwhelmingly against moving the allergy drug Singulair from prescription to over-the-counter status.
The American College of Allergy, Asthma and Immunology (ACAAI) has issued a statement regarding the use of corticosteroids for patients with allergies and asthma.