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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.
Quality / GMP | 26/05/2026 | By News Bureau
Junshi Biosciences expands toripalimab’s treatment footprint in China with regulatory approval for a new urothelial carcinoma indication, strengthening immunotherapy options for patients with advanced bladder cancer.
Quality / GMP | 25/05/2026 | By News Bureau
Qihan Biotech Secures US FDA IND Clearance for Next-Generation Universal CAR-T Therapy QT-019C
Qihan Biotech has received US FDA Investigational New Drug clearance for QT-019C, an off-the-shelf universal CAR-T therapy designed to improve safety, accessibility and treatment outcomes for patients with autoimmune diseases.
Quality / GMP | 22/05/2026 | By News Bureau | 131
Bayer Receives FDA Priority Review for Kerendia in Type 1 Diabetes-Related Kidney Disease
Bayer receives US Food and Drug Administration (FDA) Priority Review (PR) for supplemental approval of Kerendia to treat adults with Type 1 Diabetes (T1D) and Chronic Kidney Disease (CKD), potentially becoming the first Mineralocorticoid Receptor Antagonist (MRA) approved for this patient population.
Quality / GMP | 22/05/2026 | By News Bureau
Sunrise Air Receives US FDA Clearance, Expanding Access to At-Home Sleep Apnoea Diagnosis
Sunrise Air, Sunrise Group’s FDA-cleared next-generation home sleep testing device, combines AI-powered analysis and advanced sensor technology to deliver accessible, clinically robust sleep apnoea diagnosis from home.
Quality / GMP | 21/05/2026 | By News Bureau
Accord BioPharma has received US FDA approval for Immgolis and Immgolis Intri, the first golimumab biosimilars approved in the United States for rheumatoid arthritis and ulcerative colitis treatment.
Quality / GMP | 19/05/2026 | By News Bureau
Racura Oncology Advances RC220 to Higher Dose Level in Phase 1 CPACS Cancer Trial
Racura Oncology has received approval from the Safety Review Committee to escalate the dose of investigational cancer therapy RC220 in its phase 1 CPACS clinical trial following positive safety findings in advanced metastatic cancer patients.
Quality / GMP | 19/05/2026 | By News Bureau
Chugai Secures World's First Tumour-Agnostic Approval for ALK Inhibitor Alecensa in Japan
Chugai Pharmaceutical has received regulatory approval in Japan for the expanded use of Alecensa (alectinib) in advanced or recurrent ALK fusion-positive solid tumours, marking the world’s first tumour-agnostic approval for an ALK inhibitor.
Quality / GMP | 19/05/2026 | By News Bureau
Lundbeck Secures Orphan Drug Designation in Japan for Asedebart Targeting Rare Endocrine Disorders
Lundbeck has received orphan drug designation in Japan for asedebart, an investigational ACTH-targeting therapy being developed for congenital adrenal hyperplasia and Cushing’s disease.
Quality / GMP | 18/05/2026 | By News Bureau
FDA Clears IND Application for Chengdu Origen's Gene Therapy Targeting Hypertrophic Cardiomyopathy
Chengdu Origen Biotechnology and Vanotech have received US FDA clearance to begin clinical evaluation of KHN921, a potential first-in-class gene therapy designed to address the genetic root cause of hypertrophic cardiomyopathy linked to MYBPC3 mutations.
Quality / GMP | 16/05/2026 | By News Bureau
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