The expanded program allows patients to fill prescriptions either at a local pharmacy or through home delivery via LillyDirect
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices
Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
PBGENE-DMD is designed to permanently correct mutations in the dystrophin gene between exons 45 and 55, the “hot-spot” region affecting roughly 60% of DMD patients
Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa
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