The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market
The multimillion-dollar facility combines discovery and early-phase scale-up capabilities with R&D labs and two pilot plants
New 35,000-square-foot facility in Winter Park will expand RLT manufacturing footprint to optimize delivery for patients across southeastern US
The mPTP plays a key role in mitochondrial dysfunction, inflammation, and neuronal death in neurodegenerative diseases
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
The guidelines also support reusing tenofovir and abacavir in later regimens for improved outcomes, cost savings, and programmatic efficiency
This drug candidate, which is currently progressing through pivotal clinical studies, has the potential to become the first add-on therapy for schizophrenia patients who do not respond adequately
The new assets expand Biocon Biologics’ already robust oncology portfolio, which now includes 17 cancer therapies
Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis
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