FDA extends by three months its review of an Orca Bio BLA for its experimental cell therapy Orca-T, indicated for treating a range of hematologic mali...
Xbrane Biopharma says it plans to resubmit a BLA before June for ranibizumab, a biosimilar copy of Genentechs Lucentis, which is indicated for treatin...
Eli Lilly wins FDA approval for Foundayo (orforglipron), a once-daily oral treatment for adults with obesity or those who are overweight with related ...
Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should correct, but it shoul...
FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing practices for active pha...
A Washington Legal Foundation background document suggests that Congress change direct-to-consumer disclaimer rules to recognize the availability of s...
Researchers at the University of Cincinnati begin a new study to investigate whether widely used diabetes and weight-loss drugs could help prevent or ...
FDA denies a 2024 Aimed Alliance petition asking for a guidance on human drug importation by alternative funding programs.
