Approvals
The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.
The FDA approved Pluvicto (targeted radioligand therapy) for use in adults with PSMA-positive mCRPC that has already metastasized to other body parts.
Esai, Biogen, Diadem and ProMis all presented their findings on biomarker research at this year’s International Conference on Alzheimer’s and Parkinson’s Diseases.
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara.
Merck’s Keytruda has become an approved treatment for yet another indication: unresectable or metastatic advanced endometrial carcinoma. Know more about it here.
Ztalmy is Marinus’ oral suspension medication for patients ages two years and older who experience seizures linked with cyclin-dependent kinase-like 5 deficiency disorder.
BMS achieved a monumental milestone when the U.S. Food and Drug Administration approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of melanoma.
It was a busy week for clinical trial announcements. Here’s a look.
Lamassu Bio, Inc. is setting its sights on the unmet needs of the pharmaceutical industry as it announces a new venture to develop therapeutics for cancer.
Eiger BioPharmaceuticals announced that its COVID-19 therapeutic, Peginterferon Lambda reduced the risk of hospitalization and emergency room visits by 50%.
PRESS RELEASES