FDA approves a BioMarin Pharmaceutical BLA for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with severe hemophilia A.
FDA sends Alvotech a complete response letter for its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVies Humira (adalimumab)...
FDA clears two Roche assays that measure two biomarkers of Alzheimer's pathology beta-amyloid and tau proteins in adults over 55 being diagnosed wit...
FDAs Oncology Center of Excellence and other researchers stress the need to prospectively improve the diversity of cancer trial participants.
FDA clears a Cresilon 510(k) for Cresilon Hemostatic Gel to rapidly control bleeding without the need for manual pressure.
FDA publishes a draft guidance with recommendations on information to go in regulatory submissions for patient-matched guides to orthopedic implants.
FDA and National Cancer Institute researchers document an increase in oncology drug approvals since 2000 that they expect to continue into the future.
CBER issues a revised guidance agenda for 2023 with 13 likely guidances in three categories.
