The FDA Arthritis Advisory Committee voted 10 to 7 in favor of approval of Ofev for the treatment of systemic sclerosis associated with interstitial lung disease.
The FDA has approved the AirDuo Digihaler for the treatment of asthma in patients aged 12 years and older.
According to results from the MINISTONE-2 trial, baloxavir marboxil (Xofluza) was found to be safe and effective in children 1 to less than 12 years old with an influenza infection.
The Food and Drug Administration (FDA) has approved Dupixent (dupilumab; Sanofi and Regeneron) as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis.
The Drug Enforcement Agency (DEA) has designated Sunosi (solriamfetol; Jazz Pharmaceuticals) a Schedule IV controlled substance.
The approval was based on data from 83 patients with SCLC who were enrolled in either the KEYNOTE-028 or KEYNOTE-158 trials.
The CDC announced an expected 3 to 10 month shortage of Aplisol used as an aid in the diagnosis of tuberculosis.
The FDA’s Antimicrobial Drugs Advisory Committee voted in favor of pretomanid, as part of a combination regimen with bedaquiline and linezolid, for the treatment of pulmonary extensively drug resistant, treatment intolerant, or nonresponsive multidrug resistant tuberculosis.
The Food and Drug Administration has approved two new self-administration options for Nucala.
The FDA has expanded the approval of Zerbaxa to include treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in pediatric patients.
