Recent applications for approval also include another DMD therapy, another hemophilia B gene therapy, and a new antibiotic.
While US Food and Drug Administration approvals have been enjoying a mid-summer respite, a handful of companies beat the heat to bring new applications to the agency.
Six novel agent submissions have been revealed since mid-June, ranging across the therapeutic landscape from oncology and hematology to chronic...
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George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.
The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.
George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.
The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.
