BioNotebook: Dyax, MacroGenics, Vivaldi and Rexahn

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.

Following an FDA complete response in 2022, Gilead is getting ready to refile bulevirtide for hepatitis D. The drug already is approved in the EU, UK and elsewhere.

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Chinese producers of novel vaccines are increasingly pivoting to developing markets overseas in the face of a collapse in their domestic sales.