Elscint to market Agfa Drystar in US:
This article was originally published in Clinica
Elscint will sell Agfa's dry digital imaging system, Drystar 2000, in the US. Elscint will offer the Drystar with its multi-modality OmniPro workstations and nuclear medicine equipment. Drystar produces 10" X 8" (25.4 X 20.3 cm) images in 16.7 million colours or 256 shades of grey and is DICOM compatible.
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.