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CDER and CBER launch the Rare Disease Evidence Principles process intended to bring greater speed and predictability to the review...[ Price : $8.95]
Memos posted on FDAs Web site from CBER director Vinay Prasad suggest the agency is raising the bar on future Covid-19 vaccination...[ Price : $8.95]
FDA accepts for review an Achieve Life Sciences NDA for cytisinicline, an investigational treatment for helping those seeking to q...[ Price : $8.95]
Reuters reports that drug manufacturers are turning to artificial intelligence to reduce animal testing and cut costs and time in ...[ Price : $8.95]
FDA approves two new denosumab biosimilars from Shanghai Henlius Biotech and Organon for treating osteoporosis and cancer-related ...[ Price : $8.95]
Merck says its oral PCSK9 inhibitor met all primary and secondary endpoints in the CORALreef Lipids Phase 3 trial.[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at the Las Vegas, NV-based AnazaoHealth compounding facili...[ Price : $8.95]
FDA policy and regulatory expert Steven Grossman warns that the agencys current trajectory risks undermining its effectiveness by ...