FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Covid Test EUA Priorities Updated

[ Price : $8.95]

FDA updates Covid test FAQs with an explanation of current agency priorities for reviewing test EUA requests.

MPM Medical Recalls Contaminated Regenecare Hydrogel Lot

[ Price : $8.95]

FDA says MPM Medical has recalled one lot of Regenecare HA Hydrogel due to bacterial contamination.

Former CBER Reviewer Joins NDA Partners

[ Price : $8.95]

Former CBER investigator and reviewer John Godshalk joins NDA Partners as an expert consultant.

Viveve Gains Clearance to Increase Manufacturing

[ Price : $8.95]

FDA clears a Viveve Medical 510(k) to expand its manufacturing capacity for its consumable treatment tips used with the companys C...

Janssen Pharma BLA for Lung Cancer

[ Price : $8.95]

Janssen Pharmaceutical files a BLA for amivantamab for treating certain patients with metastatic non-small cell lung cancer.

Medication Errors with Tranexamic Acid Injection: FDA

[ Price : $8.95]

FDA alerts health care professionals about the risk of inadvertent intrathecal administration with tranexamic acid injection, whic...

Ublituximab and Umbralisib BLA for Lymphocytic Leukemia

[ Price : $8.95]

TG Therapeutics begins a rolling BLA submission for ublituximab in combination with umbralisib as a treatment for patients with ch...

SARS-CoV-2 Reference Panel Updated

[ Price : $8.95]

FDA publishes the latest update to the SARS-CoV-2 reference panel of standardized samples.

FDA Approves Vanda for Rare Sleep Disorder

[ Price : $8.95]

FDA approves a Vanda Pharmaceuticals NDA for Hetlioz (tasimelteon) capsule and liquid formulations for treating adults and childre...

Advisory Panel to Discuss Moderna Covid Vaccine 12/17

[ Price : $8.95]

Federal Register notice: FDA announces a 12/17 advisory committee meeting to discuss an emergency use authorization request by Mod...