FDA approves an emergency use authorization for InflaRxs Gohibic to treat some hospitalized Covid-19 patients.
FDA outlines research into potential pharmacodynamic biomarkers for biosimilar development.
Federal Register notice: FDA establishes a docket to obtain information and comments to help assess whether in-home disposal products can be expected ...
CBER director Peter Marks says Covid-19 vaccine makers will be given advice in June on the next booster vaccine composition for fall injections.
Phathom Pharmaceuticals says it will resubmit an NDA for vonoprazan for treating erosive esophagitis, and a post-approval supplement for Voquezna Trip...
FDA accepts for review two Pfizer Supplemental NDAs for Braftovi (encorafenib) and Mektovi (binimetinib) and their use in patients with metastatic non...
FDA clears a BC3 Technologies 510(k) for its SEAL Hemostatic Wound Spray.
FDA says it is requiring opioid analgesic manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as...
