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Lupin Receives US FDA EIR for Ankleshwar Manufacturing Facility
Lupin has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Ankleshwar facility following the successful closure of a product-specific pre-approval inspection conducted in March 2026.
Asahi Kasei Life Science Acquires License for Novel ADC Technology from The Noguchi Institute
Asahi Kasei Life Science Secures Rights to Novel Antibody Drug Conjugate (ADC) Technology from The Noguchi Institute to Advance Safer and More Efficient Cancer Therapies
Solu Therapeutics Receives FDA Fast Track Status for STX-0712 in CMML Treatment
Solu Therapeutics receives US Food and Drug Administration (FDA) Fast Track designation for STX-0712 to treat chronic myelomonocytic leukemia (CMML), supporting accelerated development for patients with relapsed or treatment-resistant disease and limited therapeutic options.
Ribo Submits Phase 2 EMA Trial Application for siRNA Therapy in Thromboembolic Disease
Ribo submits a Phase 2 clinical trial application to the European Medicines Agency (EMA) for its siRNA therapeutic targeting thromboembolic disease, advancing development of innovative oligonucleotide-based therapies for Coronary Artery Disease (CAD)
Pharming Secures EU Approval for Joenja as First Targeted Treatment for Rare Immune Disorder APDS
Pharming Group has received European Commission approval for Joenja, expanding treatment access for patients with activated PI3K delta syndrome and strengthening therapeutic options for rare immune disorders.
Jade Biosciences Doses First Patient in Phase 2 Trial of JADE101 for IgA Nephropathy
Jade Biosciences announces first patient dosing in the phase 2 JUNIPER trial evaluating JADE101 for IgA nephropathy, with interim clinical data expected in 2027.
Merz Therapeutics and Kvvit Sign China Deal for INBRIJA Parkinson's Therapy
Merz Therapeutics and Kvvit sign an exclusive agreement for commercialization of INBRIJA in mainland China, Hong Kong, and Macao, expanding access to advanced treatment options for Parkinson's disease patients.
Eli Lilly and Company reports that a single dose of investigational gene-editing therapy VERVE-102 delivered sustained reductions in PCSK9 and LDL cholesterol for up to 18 months in high-risk cardiovascular patients.
AbbVie Receives Positive CHMP Opinion for MAVIRET in Acute Hepatitis C Treatment
AbbVie receives a positive CHMP opinion for MAVIRET to treat acute hepatitis C, supported by Phase 3 data demonstrating safety and efficacy in adults with acute HCV infection.
AGC Biologics to Manufacture Teikoku Seiyaku's rhMMP-7 Drug Substance
AGC Biologics will provide process development and GMP manufacturing services for Teikoku Seiyaku’s rhMMP-7 therapy, supporting development of the novel biologic through its global microbial network in Germany and Japan.
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