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Emcure Takes Full Ownership of Gennova, Strengthens Focus on Biologics and Biosimilars
Emcure Pharmaceuticals has acquired the remaining minority stake in Gennova Biopharmaceuticals, making it a wholly owned subsidiary while appointing Samit Mehta to lead the company’s next phase of growth in biologics and biosimilars.
Santhera Expands Agamree Distribution Partnership with Biomedica Across Five Additional Markets
Santhera Pharmaceuticals has expanded its exclusive distribution partnership with Biomedica to include Georgia, Kazakhstan, Belarus, Azerbaijan and Uzbekistan, extending access to Agamree (vamorolone) for patients with Duchenne muscular dystrophy across additional underserved markets.
TolerogenixX Secures EU Orphan Drug Designation for MIC-Lx in Living-Donor Kidney Transplantation
European Commission grants orphan status to Tolerogenix’s personalized cell therapy following EMA recommendation, strengthening its regulatory pathway alongside recent PRIME designation.
Fischer Medical Ventures Strengthens AI Life Sciences Partnership with Nanyang Biologics
Fischer Medical Ventures and Nanyang Biologics are expanding their strategic collaboration to advance Artificial Intelligence (AI)-powered life sciences research and biotechnology innovation in India.
GSK's Jemperli (dostarlimab) achieved durable complete responses in dMMR/MSI-H locally advanced rectal cancer, with potential to avoid chemotherapy, radiation, and surgery in some patients.
US FDA Accepts BioMarin's sNDA for VOXZOGO in Achondroplasia
The US Food and Drug Administration (FDA) has accepted BioMarin's sNDA for VOXZOGO in achondroplasia, supported by long-term safety and efficacy data, including adult height, body proportionality, and arm span outcomes.
US FDA Approves Leqembi Iqlik Subcutaneous Injection for Early Alzheimer's Disease
The US Food and Drug Administration (FDA) has approved Leqembi Iqlik (lecanemab-irmb) as a once-weekly subcutaneous starting dose for early Alzheimer's Disease (AD), with a U.S. launch planned for August 2026.
US FDA Approves Subcutaneous Sarclisa for Multiple Myeloma Across All Existing Indications
Sanofi’s SC formulation becomes the first oncology therapy approved for administration via both an on-body injector and manual subcutaneous injection, offering shorter treatment times for patients.
China Grants Priority Review to Leads Biolabs' Opamtistomig for Advanced Neuroendocrine Carcinoma
NMPA accepts biologics license application under expedited review pathway for investigational PD-L1/4-1BB bispecific antibody targeting advanced extrapulmonary neuroendocrine carcinoma after multiple prior therapies.
NMPA Reviews QMS for Vaccine and Drug GMP Compliance
China's NMPA has completed a QMS management review to strengthen vaccine and drug Good Manufacturing Practice (GMP) compliance, supporting WHO WLA standards and PIC/S regulatory requirements.
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