FDA's NDA And BLA Approvals: Radicava, Minolira, Bavencio
Executive Summary
Original new drugs and biologics recently approved by US FDA.
You may also be interested in...
Pfizer/Merck KGAA's Bavencio Gastric Cancer Failure Not As Bad As It Seems
Disappointing outcome for the companies' PD-L1 inhibitor avelumab in late-stage gastric cancer may not have implications for the drug in more valuable indications, like lung cancer.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.