Establishment Labs seeks FDA nod for Motiva breast reconstruction implants
Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation
Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation
Theracor is derived from human umbilical cord extracellular matrix (ECM) and is designed to cover, protect, and maintain a moist wound environment
The accelerated review covers WCK 5222 for multiple critical infections
The acquisition adds HLD-0915, a once-daily oral therapy for prostate cancer, to Johnson & Johnson’s nearly 20-year legacy of innovation in the disease
Applications include detailed scientific rationale and supporting clinical evidence
The Toumai platform, currently the only robotic system with US FDA Study Approval for telesurgery, enabled real-time surgical control with no compromise to patient safety
The plant is expected to enhance regional supply capabilities
Astal estimates the collaboration will generate incremental revenue of approximately Rs. 300 crore upon implementation
The partnership also sets the stage for broader collaboration on rare disease treatments
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
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