Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Caribou, Clarity, Genmab, Immorna, Legend, Okyo, Rhythm, Tetra, Triastek.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Bioinvent, Carmell, Eli Lilly, Emmaus, Iovance, Iveric, Kempharm, Novavax, Provention, Sanofi.
The U.S. FDA has finalized a rewritten draft guidance for Section 522 postmarket surveillance studies, a policy that carries a new level of stringency regarding how these studies are conducted. The final guidance calls for all subjects in such a study to be enrolled within 24 months, a deadline some in industry argued might prove unduly burdensome in some instances.
Provention Bio Inc. scored approval from the U.S. FDA of the BLA for Tzield (teplizumab-mzwv), an intravenously given, anti-CD3-directed antibody, as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients ages 8 and older with stage 2 T1D.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc Medical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Ardelyx, Ascletis, Beigene, PTC, Skye.
The problem with notified body (NB) capacity in the European Union is well known, but a recent survey of NBs suggests that more than 17,000 certificates for medical devices and active implanted devices issued under the legacy regulation are set to expire by the end of 2024. More troubling might be the fact that the number of standing applications dwarfs the number of completed applications by a ratio of more than four to one, a gap that continues to grow as calendar year 2022 unwinds.
With a 9-4 vote, the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee bucked FDA reviewers who delayed PDUFA dates, issued a complete response letter and two formal dispute resolution requests for Ardelyx Inc.’s tenapanor as a hyperphosphatemia therapy for adults on dialysis with chronic kidney disease (CKD).
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