Page 5 - Boxed Warning News Today

The FDA has approved Ultomiris for patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 (AQP4) antibody positive.

Vafseo is an oral reversible inhibitor of hypoxia-inducible factor (HIF)-prolyl-4-hydroxylases (PH)1, PH2, and PH3.

Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI for the chronic treatment of adults with pulmonary arterial hypertension (PAH). The newly-approved drug is a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.

In a significant milestone for pulmonary arterial hypertension (PAH) patients, Johnson & Johnson has announced the approval of OPSYNVI.

The approval, which marks the first for a once-daily, single-tablet combination therapy for pulmonary arterial hypertension, is based on findings from the phase 3 A DUE study.

Gottfried E. Konecny, MD, discusses the FDA approval of mirvetuximab soravtansine for patients with FRα-positive, platinum-resistant ovarian cancer.

OPSYNVI® combines two proven treatments with established efficacy and safety profiles into one tablet to be taken once daily, offering an option that helps to...

The approval marks the first and only once-daily single-tablet combination therapy for patients with pulmonary arterial hypertension.

/PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results...

Randomized Phase 2 study met the primary endpoint in patents with hidradenitis suppurativa , reinforcing efficacy and safety profile of ruxolitinib cream Results presented as a late-breaking...