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China Approves Jaypirca for Relapsed CLL and SLL Patients
Jaypirca (pirtobrutinib) by Innovent Biologics has been approved in China for the treatment of adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The BTK inhibitor is designed to overcome resistance associated with prior covalent BTK therapies.
YD Bio USA to Serve as Exclusive US Agent for YC Biotech's FDA Submissions
YD Bio Limited has announced that its subsidiary, YD Bio USA, Inc., has entered into a master strategic alliance agreement with YC Biotech Co Ltd to establish a cross-border regulatory platform focused on US Food and Drug Administration (FDA) submissions.
Quotient Sciences Expands Commercial Supply Partnership with Ipsen for Ultra-Rare FOP Therapy
Quotient Sciences has announced an extension of its commercial supply partnership with Ipsen to manufacture a treatment for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder affecting fewer than 1,000 people worldwide.
Lupin Limited Receives USFDA EIR for Goa Manufacturing Facility
Lupin Limited has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration for its manufacturing facility in Goa. The report follows a recent inspection of the site and marks the formal closure of the regulatory review process.
GSK's Linerixibat Granted Priority Review in China for Cholestatic Pruritus in PBC
China’s drug regulator has accepted GSK’s linerixibat for priority review to treat cholestatic pruritus in primary biliary cholangitis, supported by Phase III data showing significant and sustained itch relief.
Mevion Medical Systems Secures CE Mark for MEVION S250-FIT Proton Therapy System
Mevion Medical Systems has received CE Marking under Regulation (EU) 2017/745 (EU MDR) for its MEVION S250-FIT Proton Therapy System, marking a major regulatory milestone for the company.
Asahi Kasei Pharma Secures Global License from Alchemedicine to Strengthen Autoimmune Pipeline
Asahi Kasei Pharma has expanded its drug discovery pipeline through an exclusive global licensing agreement with Alchemedicine for novel lead compounds targeting a single, undisclosed mechanism.
Novo Nordisk Signs USD 2.1 Billion Pact with Vivtex to Develop Oral Obesity Therapies
Novo Nordisk has entered into a strategic collaboration with US-based Vivtex to develop next-generation oral biologic therapies for obesity, diabetes and related metabolic conditions.
Argo Biopharma to Present Phase II Interim Data on BW-20805 for HAE at AAAAI 2026
Argo Biopharma’s investigational siRNA therapy BW-20805 showed sustained reduction in hereditary angioedema attack rates and plasma prekallikrein levels, with favorable safety, in Phase II interim data selected for AAAAI 2026.
Mahzi Therapeutics Doses First Patient in Phase I/II Trial of Gene Therapy for Pitt Hopkins Syndrome
Mahzi Therapeutics has dosed the first patient in its global Phase I/II UNITE study evaluating investigational gene therapy MZ-1866 for Pitt Hopkins syndrome, a rare neurogenetic disorder caused by TCF4 mutations.
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