APL Healthcare’s Unit-IV classified as VAI by the USFDA
This inspection is now closed
This inspection is now closed
Marks significant milestone for breakthrough biologic to treat rare blood cancers
The approval comes after a systematic review of published literature
Phase I EPRAD study of DT-9081 demonstrated a favorable safety profile
Giredestrant shows promise despite missing primary goal
The new equipment will be installed at Codis’ 400,000-square-foot Haverhill facility and is expected to be operational by 2027
The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth
Indomo’s ClearPen system combines a proprietary self-injection device and microneedle with a modernized triamcinolone acetonide formulation
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