Sunovion Pharmaceuticals Inc.’s apomorphine sublingual film (APL-130277), a dopamine agonist the company will market as Kynmobi, has won FDA approval for the acute intermittent treatment of motor fluctuations (off episodes) associated with Parkinson’s disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Astrazeneca, Beigene, Bluebird, BMS, Daiichi, Evofem, Geron, Intercept, Orphazyme, Sunovion.
The pandemic-driven FDA guidance for device shortages addressed a topic that has been discussed for devices for some time despite lack of congressional action, but shortages may be ordinarily interpreted as a consequence of reduced or terminated production that crimps supplies. That interpretation has been expanded for the duration of the COVID-19 pandemic, however, to include circumstances in which demand exceeds supply even when the manufacturer sustains normal production levels, in which case the manufacturer is liable for reporting the shortage to the FDA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomérieux.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Alethia, Anavex, Appili, Astellas, Calcimedica, Chiesi, Fibrogen, Genexine, I-Mab, Passage Bio.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Aetion, Boston Scientific Neuromodulation, Nevro.
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