FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Elevar Submits Lirafugratinib NDA for Bile Duct Cancer

[ Price : $8.95]

Elevar Therapeutics files an NDA for lirafugratinib as a second-line treatment for patients with cholangiocarcinoma whose tumors h...

Sen. Scott Bill to Require Country-of-Origin on Rx Labels

[ Price : $8.95]

Sen. Rick Scott (R-FL) introduces legislation that would require prescription drug labels in the U.S. to disclose where drugs and ...

FDA Approves Yuvezzi Combination Eye Drop for Presbyopia

[ Price : $8.95]

FDA approves Tenpoint Therapeutics Yuvezzi as the only combination eye drop approved to treat presbyopia in adults.

Agency Clarifies Clinical Decision Support Software

[ Price : $8.95]

FDA posts an updated guidance clarifying when clinical decision support software functions fall outside the definition of a regula...

FDA Staffing Shortages are Lengthening Trial Planning

[ Price : $8.95]

An industry consultant says reduced FDA staffing levels and high turnover are extending regulatory timelines and forcing drug deve...

Kennedy Ally Says Makary Blocking Covid Shot Withdrawal

[ Price : $8.95]

Axios reports that the vice chair of the CDC Advisory Committee on Immunization Practices says the Pfizer and Moderna Covid mRNA v...

FDA Annual Report on CDRH International Harmonization

[ Price : $8.95]

CDRH reports on its 2025 MDUFA 5 activities to promote international harmonization.

Suggestions to Revise Hatch-Waxman Skinny Label Provisions

[ Price : $8.95]

A Congressional Research Service backgrounder explains options Congress could consider to resolve some issues with the skinny labe...

Summit BLA for Lung Cancer Therapy

[ Price : $8.95]

FDA accepts for review a Summit Therapeutics BLA seeking approval for ivonescimab in combination with chemotherapy in patients wit...

FDA Politicization Depth and Breadth Unprecedented: Professor

[ Price : $8.95]

University of Southern California public policy professor Genevieve Kanter airs concerns about the impact of the many changes that...