FDA Approves AstraZeneca COPD Medicine

Approval was based on the combined results from five studies of adults with supraventricular tachycardia.

Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for treatment with Ziihera.

Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.

Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) provides a chemotherapy-free treatment option for patients with HER2-positive biliary tract cancer, addressing a critical unmet need with promising efficacy and improved quality of life.

The resubmission for Dupixent includes new data in pediatric patients with chronic spontaneous urticaria.

Kebillidi is the first gene therapy to gain FDA approval for the treatment of aromatic L-amino acid decarboxylase deficiency.