Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...
The US Food and Drug Administration (FDA), in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for biological products as well as a ...
This news isn’t hard to swallow. Researchers at Yale University have identified a low-cost prescription drug already on the ...
Health system pharmacists and clinicians are monitoring a wave of drug approvals expected throughout 2026, including first-in-class therapies and expanded uses of existing drugs with implications for ...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you ...
Key Takeaways. Draft guidance targets reduction/elimination of nonhuman primate testing for monoclonal antibodies, signaling higher regulatory receptivity to alternative nonclinic ...
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