EU approves Xofluza for influenza in patients aged 12 years and above.- Roche
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Regeneron Pharmaceuticals, Inc. announced the FDA as accepted for review the Eylea (aflibercept) Injection supplemental Biologics License Application (sBLA) for an every 16-week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy (DR). The target action date for the FDA decision is February 28, 2023.
VBI Vaccines Inc. a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, announced that new data from a follow-up analysis of a subset of participants from the pivotal Phase III study (PROTECT) of the Company’s 3-antigen prophylactic hepatitis B (HBV) vaccine, were presented in an oral presentation at The International Liver Congress 2022 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), which took place on June 26, 2022.
Positive high-level results from a planned interim analysis of the AEGEAN Phase III trial showed treatment with AstraZeneca’s Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete response (pCR) compared to neoadjuvant chemotherapy alone for patients with resectable non-small cell lung cancer (NSCLC).