Drug Approval
4 articles
FDA Pilot Program Accelerates Clinical Trials for Faster Drug Approvals
The FDA is now aiming to cut up to a year from early-stage clinical trials, following a recent decision to reduce required trials for drug approval from two to one.
Drug companies ask FDA commissioner to pause new voucher program
Just months after its announcement, the FDA's Commissioner’s National Priority Voucher Program (CNPV), designed to slash drug approval times to as little as one month, is already facing calls from maj
HHS Authorizes Experimental Ebola Therapy for High-Risk Exposures
The U.S. Department of Health and Human Services (HHS) has authorized an experimental monoclonal antibody treatment, MBP-134, for Americans facing high-risk Ebola exposures. This move sidesteps tradit
FDA advisory panel rejects AstraZeneca breast cancer drug
A U.S. Food and Drug Administration advisory committee voted 3 to 6 against the benefit-risk profile of AstraZeneca's breast cancer drug camizestrant, according to AstraZeneca . This decision creates