Avillion/AstraZeneca’s Budesonide/Albuterol Combo For Asthma Has ‘Uncertain’ Pediatric Benefit
US FDA is asking an advisory committee whether extrapolation of adult data is appropriate to bridge uncertainties in efficacy for asthma patients under age 18 years; metered-dose inhaler would be the first combination product approved in the US containing an inhaled corticosteroid and a short-acting beta2-adrenergic agonist.
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Keeping Track: New Claims For Tukysa, Brukinsa; US FDA Wants More Patients To Support Donanemab, Pediatric Airsupra Bids
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The US Food and Drug Administration has approved AstraZeneca and Avillion’s respiratory drug Airsupra, making it the only rescue medication cleared for as-needed use to reduce risk of asthma exacerbations.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.