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Soleno Withdraws EU Filing for Rare Disease Drug Ahead of Neurocrine Takeover
Soleno Therapeutics has withdrawn its European marketing application for Vykat XR, a treatment for hyperphagia associated with Prader-Willi syndrome, ahead of its planned acquisition by Neurocrine Biosciences.
ATLATL Partners with Daiichi Sankyo to Boost APAC Biotech Innovation
ATLATL partners with Daiichi Sankyo to accelerate APAC biotech innovation through its Super Server platform, offering integrated R&D infrastructure, technical services, and investment support.
Lupin Secures US FDA Approval for Dapagliflozin Tablets in US
Lupin secures US FDA approval for Dapagliflozin Tablets 5 mg and 10 mg in the US, bioequivalent to Farxiga.
Merck Starts Tender Offer to Buy Terns Pharmaceuticals
Merck launches a tender offer to acquire Terns Pharmaceuticals, with plans to make it a wholly owned subsidiary.
Okami Medical Enrolls First Patient in ALPHA Registry for LOBO Vascular Occlusion System
The multicentre study will evaluate the safety and effectiveness of the LOBO device in treating peripheral vascular conditions, with plans to enroll up to 500 patients.
Nuvalent Submits NDA to FDA for Neladalkib in Advanced ALK-Positive Lung Cancer
The investigational ALK inhibitor, backed by Phase I/II trial data, targets treatment-resistant non-small cell lung cancer and has received breakthrough and orphan drug designations.
Denali Regains Full Rights to DNL593 After Takeda Ends Collaboration
The biotech firm will independently advance its investigational therapy for frontotemporal dementia, with Phase I/II trial results expected by 2026.
MedGenome Study Highlights Role of RNA-Based NGS in Improving Sarcoma Diagnosis in India
India’s first prospective study finds that RNA sequencing enhances diagnostic accuracy and influences treatment decisions in complex sarcoma cases, supporting precision oncology in resource-limited settings.
Artivion Secures US FDA Approval for Endospan's NEXUS Aortic Arch System
Artivion, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced that the US Food and Drug Administration (FDA) has approved the premarket approval application (PMA) for the NEXUS Aortic Arch System, developed by Endospan Ltd. (Endospan), Artivion's long-standing partner.
Sanofi's Lunsekimig Shows Promising Phase II Results in Asthma and Nasal Polyps Studies
The novel dual-targeting Nanobody met primary and key secondary endpoints in asthma and chronic rhinosinusitis trials, demonstrating improved outcomes and a favourable safety profile.
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