Most Recent Articles by Steve Duffy
Through Bluetooth technology, clinicians and patients will be able to share and monitor inhaler usage.
Bronchiolitis obliterans is the leading cause of morbidity and mortality in the pulmonary transplant population with ≥50% of patients who receive a lung transplant developing the condition within 5 years.
The Company is currently conducting a Phase 3 trial (APeX-2) and a long-term safety study (APeX-S) evaluating 2 doses of the treatment.
Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension.
The draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the New Drug Application (NDA) process and "is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription," said Gottlieb in a press statement.