FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

BioMarin Gene Therapy for Hemophilia A OKd

[ Price : $8.95]

FDA approves a BioMarin Pharmaceutical BLA for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with s...

Alvotech Complete Response Due to Inspection

[ Price : $8.95]

FDA sends Alvotech a complete response letter for its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVies...

2 Roche Assays Cleared for Alzheimers

[ 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...

Prioritize Cancer Trial Diversity: Researchers

[ Price : $8.95]

FDAs Oncology Center of Excellence and other researchers stress the need to prospectively improve the diversity of cancer trial pa...

Cresilon Hemostatic Gel Cleared

[ Price : $8.95]

FDA clears a Cresilon 510(k) for Cresilon Hemostatic Gel to rapidly control bleeding without the need for manual pressure.

Orthopedic Implant Guide Guidance

[ Price : $8.95]

FDA publishes a draft guidance with recommendations on information to go in regulatory submissions for patient-matched guides to o...

Oncology Drug Approval Trends

[ Price : $8.95]

FDA and National Cancer Institute researchers document an increase in oncology drug approvals since 2000 that they expect to conti...

CBER Updates 2023 Guidance Agenda

[ Price : $8.95]

CBER issues a revised guidance agenda for 2023 with 13 likely guidances in three categories.

3 GOP Senators Push FDA on Chinese Cancer Drugs

[ Price : $8.95]

Republican Sens. Scott, Vance, and Braun criticize FDAs decision to allow the importation of some Chinese-approved cancer drugs to...

Comments on OPDP Quantitative Claims Research

[ Price : $8.95]

Two stakeholders raise questions about proposed Office of Prescription Drug Promotion research into quantitative claims in direct-...