As expected, the FDA granted an approval for Amondys 45 (casimersen), a new Duchenne muscular dystrophy (DMD) therapy developed by Sarepta Therapeutics Inc.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays. A final guidance the FDA released in November suggests that the days of ignoring segments of the intended treatment population until safety signals flare in real-world use are coming to an end.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aquestive, Bluebird, Cansino, Exelixis, Gannex, J&J, Retrotope, RDIF, Sinopharm, Viiv.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim, Antengene, Kura, Pfizer, RDIF, Teleflex.
Briefing documents released by the FDA related to the Vaccines and Related Products Advisory Committee meeting slated for Friday suggest that the COVID-19 vaccine from Johnson & Johnson (J&J) will sail smoothly to an emergency use authorization.
In the shadow of the COVID-19-related deaths of more than half a million Americans and far more deaths across the world, the Biden administration is reportedly rethinking its position on a proposal before the World Trade Organization to waive intellectual property protection for SARS-CoV-2 vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Elicio, Hoth, Iaso, Innovent, Neoimmunetech, Noven, Ocugen, RDIF, Regeneron, Sanofi, Scpharmaceuticals.
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