AstraZeneca Vice President, Head of Breast Cancer Franchise, Discusses Impact of Truqap Approval

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.

Pharma looks to take advantage of expanded access programs across Asia-Pacific region.

Decision to submit the Biologics License Application of datopotamab deruxtecan was based on feedback from a previously withdrawn application to the FDA for nonsquamous non-small cell lung cancer.

Approval of Aucatzyl was based on results of the FELIX trial, which demonstrated a 63% overall complete remission rate among efficacy-evaluable patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

The FDA’s clinical hold for the COVID and influenza vaccine trials was a result of a report of a serious adverse event involving motor neuropathy in a participant from a prior Phase II trial.