FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Sends Sesen Bio a Complete Response Letter

[ Price : $8.95]

FDA issues Sesen Bio a complete response letter on its BLA for Vicineum (oportuzumab monatox-qqrs) for treating BCG-unresponsive n...

CDERs Ellis Unger Retiring After 24 Years at Agency

[ Price : $8.95]

CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger retires to spend more time with family.

Drug User Fee Rates for FY 2022

[ Price : $8.95]

Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2022.

Pfizer, Moderna Booster Authorized for Immunocompromised

[ Price : $8.95]

FDA amends the emergency use authorizations for both Pfizer-BioNTechs and Modernas Covid-19 vaccines to allow for the use of an ad...

Ipsen Withdraws NDA Palovarotene for More Analyses

[ Price : $8.95]

Ipsen withdraws its NDA palovarotene, indicated for preventing heterotropic ossification as a potential treatment for people livin...

SyntrFuge System Cleared for Adipose Tissue

[ Price : $8.95]

FDA clears a Syntr Health Technologies 510(k) for the SyntrFuge System and its use in surgical specialties when the transfer of ha...

Researchers Get Jail Time for Falsifying Clinical Trial Data

[ Price : $8.95]

A Florida federal judge sentences two people to jail time and restitution for participating in a conspiracy to falsify clinical tr...

CDRH Met or Exceeded Strategic Goals: Report

[ Price : $8.95]

CDRH says it met or exceeded strategic goals in the period 2018-2020.

FDA Approves Keytruda Plus Lenvima for Some Cancers

[ Price : $8.95]

FDA approves Mercks Keytruda plus Eisais Lenvima for first-line treatment of adults with advanced renal cell cancer.

FDA Orphan Drug Designation for Allogene Cancer Drug

[ Price : $8.95]

FDA grants Allogenes ALLO-715 orphan drug status for treating multiple myeloma.