[ Price : $8.95]
FDA releases the form FDA-483 with 11 observations from an inspection at Indias Ipca Laboratories Ratlam API facility.[ Price : $8.95]
FDA approves a BioMarin Pharmaceutical BLA for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with s...[ Price : $8.95]
FDA sends Alvotech a complete response letter for its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVies...[ Price : $8.95]
FDA clears two Roche assays that measure two biomarkers of Alzheimer's pathology beta-amyloid and tau proteins in adults over 55...[ Price : $8.95]
FDAs Oncology Center of Excellence and other researchers stress the need to prospectively improve the diversity of cancer trial pa...[ Price : $8.95]
FDA clears a Cresilon 510(k) for Cresilon Hemostatic Gel to rapidly control bleeding without the need for manual pressure.[ Price : $8.95]
FDA publishes a draft guidance with recommendations on information to go in regulatory submissions for patient-matched guides to o...[ Price : $8.95]
FDA and National Cancer Institute researchers document an increase in oncology drug approvals since 2000 that they expect to conti...