FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

HHS Unveils Initiative to Accelerate U.S. Clinical Trials

[ Price : $8.95]

HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting ...

Regenxbio Gets FDA Agreement to Refile Gene Therapy BLA

[ Price : $8.95]

Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sn...

How Global Regulators Handle Cancer Drugs After FDA First Approval: Study

[ Price : $8.95]

A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that...

Ex-FDA Head Gottlieb Warns on Politicization Threatening Scientific Credibility

[ Price : $8.95]

Former FDA commissioner Scott Gottlieb urges federal health officials to restore scientific leadership at the agency's medical pro...

Former FDA Drug Chief Questions Future of Priority Voucher Program

[ Price : $8.95]

Former FDA Office of New Drugs director Peter Stein criticizes the agency's National Priority Voucher program at the DIA Global An...

FDA Regulatory Pathway Needed for Dementia Vaccine Trials: Opinion

[ Price : $8.95]

An opinion article calls on FDA to establish a formal regulatory framework for evaluating vaccines as potential interventions to p...

Merck Wins Expanded Indication for Pneumococcal Vaccine

[ Price : $8.95]

Merck says FDA has approved an expanded indication for its pneumococcal conjugate vaccine, Capvaxive, allowing its use in children...

Beam Gets OK to Begin Clinical Testing of PKU Gene-Editing Therapy

[ Price : $8.95]

FDA approves a Beam Therapeutics IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing...

FDA Approves 1st Generic Version of Flu Drug Xofluza

[ Price : $8.95]

FDA approves the first generic version of Xofluza (baloxavir marboxil), clearing Norwich Pharmaceuticals' generic tablets for the ...

Expand Some Islet Cell Transplantation Access: Senators

[ Price : $8.95]

Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type...