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Medtronic Hugo Robotic System Shows Success in Hernia Repair
Medtronic’s Enable Hernia Repair study marks the first IDE clinical trial in the US for robotic-assisted hernia surgery, evaluating the Hugo RAS system in inguinal and ventral procedures.
Senhwa Biosciences Secures US FDA Nod to Advance Pidnarulex Trial for MYC-Driven B-Cell Lymphoma
Senhwa Biosciences has received FDA clearance to begin a Phase 1b/2 trial of its novel MYC-targeting drug candidate Pidnarulex (CX-5461) in patients with B-cell lymphoma, marking a potential breakthrough in precision oncology.
Ronovo Surgical Closes Series D Financing
Ronovo Surgical secures USD 67 million in Series D funding led by JJDC, raising over USD 100 million in 2025 to advance minimally invasive surgery.
BioNTech and Duality Biologics reach major breakthrough in breast cancer trial
BioNTech and Duality Biologics have announced a significant advance in cancer drug development with the successful outcome of a Phase III trial for their investigational therapy BNT323, also known as trastuzumab pamirtecan.
FDA tightens import controls on obesity drug ingredients amid safety concerns
The Food and Drug Administration (FDA) in the USA has intensified its scrutiny of imports containing GLP-1 drug ingredients, widely used in treatments for weight loss and diabetes, following increasing concerns over safety and quality.
Hengrui Pharma Grants Braveheart Bio Exclusive Global Rights to Cardiac Myosin Inhibitor HRS-1893
Hengrui Pharma has signed an exclusive licensing deal with US-based Braveheart Bio for its Phase 3-ready cardiac myosin inhibitor HRS-1893. Braveheart will make an upfront payment of USD 65 million and a near-term payment of up to USD 10 million upon technology transfer completion, totalling USD 75 million.
Enzene Launches New Biologics Manufacturing Facility In New Jersey
India-based Enzene has inaugurated a state-of-the-art biomanufacturing facility in Hopewell, New Jersey — marking its first major manufacturing investment in the United States.
Clearpoint Prism Neuro Laser Therapy System Receives FDA Clearance for 1.5T MRI Use
ClearPoint Neuro has announced that its ClearPoint Prism Neuro Laser Therapy System has received 510(k) clearance from the US FDA for use under 1.5T MRI guidance, in addition to its previously cleared 3T MRI compatibility.
Cipla launches HUENA, maiden non-antibiotic drug in India for recurring UTIs
With HUENA, Cipla becomes the first in India to offer Methenamine Hippurate, a non-antibiotic therapy for recurrent UTIs, strengthening its fight against AMR.
Lupin's Aurangabad Facility Gets Two Observations After US FDA Inspection
The United States Food and Drug Administration (US FDA) has completed a product-specific pre-approval inspection at Lupin’s Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility, issuing two observations.
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