Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aligos, Beigene, Cynata, Dicerna, Epizyme, Hutchison, Linnaeus, Pear, Protagonist, TFF, Ultragenyx.
Four years after the EMA first approved Novartis AG's Ilaris (canakinumab) for the treatment of adult-onset Still’s disease (AOSD), the FDA has followed suit, giving it a green light in the indication following a priority review. The rare rheumatic condition usually affects younger adults and can occur as infrequently as once, but also intermittently or chronically.
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aclaris, Curevac, Foundation Medicine, Hookipa, Ipsen, Kamada, Merck, Nanobiotix, Novartis, PTC, Reneuron, TG.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akili, Arch, Edesa, Eli Lilly, Jazz, Valeo.
Two months earlier than expected, Pharmamar SA and partner Jazz Pharmaceuticals plc received an accelerated FDA approval of Zepzelca to treat relapsed metastatic small-cell lung cancer patients.
The latest FDA report card on the quality of drugs being sold in the U.S. is nothing to brag about. On a grading scale where 90% to 100% is an “A” and anything below 60% is failing, the average manufacturing site inspection score for drugs marketed in the U.S. in fiscal 2019 would be a solid “C” – or 7.4 on the FDA’s 10-point grading scale. But at least 10 sites had failing marks with scores of 5.
Just 80 days after first issuing an emergency use authorization (EUA) for oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) in treating COVID-19, the FDA is revoking that authorization in light of clinical data and scientific literature that raised questions about whether benefits of the treatment outweigh the risks.
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