FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Moderna Says Data Support Booster Shot

[ Price : $8.95]

Moderna says an analysis of a Phase 3 study of its Covid-19 mRNA vaccine supports the usefulness of a booster shot.

Revised Guide on Ferric Oxyhydroxide ANDAs

[ Price : $8.95]

Federal Register notice: FDA makes available a revised draft guidance for industry entitled Draft Guidance for Ferric Oxyhydroxide...

Info Collection on Biosimilar User Fees

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled Biosimilars User Fee Program.

AbbVie Files Rinvoq sNDA for Ulcerative Colitis

[ Price : $8.95]

AbbVie files a supplemental BLA for Rinvoq (upadacitinib) for treating certain adults with moderately to severely active ulcerativ...

FDA Approves Takedas Exkivity for Some Lung Cancers

[ Price : $8.95]

FDA approves Takedas Exkivity to treat specified non-small cell lung cancer patients identified that an approved diagnostic test.

ICH Guidance Combined: Validation of Analytical Procedures

[ Price : $8.95]

FDA says it has consolidated two ICH guidances and retitled them Q2(R1) Validation of Analytical Procedures: Text and Methodology.

FDA Releases Bad Ad Quiz

[ Price : $8.95]

FDA releases a quiz that participants can use to determine how much they know about prescription drug promotion and the Bad Ad pro...

FDA OKs Phase 1 Biomea IND Leukemia Trial

[ Price : $8.95]

FDA says Biomea Fusion can start a Phase 1 trial of its BMF-219 in some leukemia patients.

Gynesonics Sonata Fibroid Device Cleared

[ Price : $8.95]

FDA clears a Gynesonics 510(k) for the (XXXX DELETE XXX) Sonata System 2.2 for treating fibroids.

Expanded EUA for Lilly Covid-19 Prophylaxis

[ Price : $8.95]

FDA expands an Eli Lilly emergency use authorization for bamlanivimab 700 mg and etesevimab 1,400 mg administered together to prov...