US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.
The US FDA is calling on its Antimicrobial Drugs Advisory Committee to assess the potential use of five different development and regulatory pathways for antibacterial drugs targeting a single species of bacteria.
Sponsors have expressed interest in developing antibacterial drugs and monoclonal antibodies with activity against a single bacterial species that infrequently...
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines
Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.
