FDA Related News

Biologics

PD-1 Inhibitor BLA Yanked After Keytruda Approval

Agenus withdraws a BLA for balstilimab after FDA urged it to do so following Mercks recent full approval for pembrolizumab for treating cervical cance...

FDA Approves Large Photodynamic Therapy Light

FDA approves Biofronteras BF-RhodoLED XL, a red-light source for photodynamic therapy and its combination use with the companys Ameluz gel for treatin...

Human Drugs

Susvimo Eye Implant for Wet AMD Approved

FDA approves Genentechs Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for treating certain people with wet, or neo...

Federal Register

FDA Withdraws Approval for 216 ANDAs

Federal Register notice: FDA withdraws the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual report...

FDA General

Biden Meets with Potential FDA Head Califf

President Biden meets with potential FDA commissioner nominee Robert Califf in what may be the last step before an official announcement.

Federal Register

Regulatory Review Determined for Orions Nubeqa

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Orion Corp.s Nubeqa (darolutamide).

Federal Register

Comments Sought on Xenotransplantation Guideline

Federal Register notice: FDA seeks comments on an information collection extension entitled PHS Guideline on Infectious Disease Issues in Xenotranspla...

Biologics

FDA Denies Vaccine EUA Revocation Petition

FDA denies an Informed Consent Action Network petition asking it to revoke the EUAs for the Moderna and J&J Covid vaccines.

Human Drugs

Real-World Data Standards Guidance

FDA publishes a draft guidance on data standards for applicable drug submissions using real-world data.

Human Drugs

FDA Expanding Covid Work with Aetion

FDA expands its Covid-19 regulatory science work with Aetion.