Regulatory Pathway– tag –
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Henlius Gains NMPA IND Approval for HLX48, a Bispecific c-Met/EGFR Antibody-Drug Conjugate for Solid Tumors
FirstWord Pharma China Overview Shanghai Henlius Biotech, Inc. announced that its self-developed c-Met/EGFR bispecific antibody-drug conjugate (ADC), HLX48, has received Investigational New Drug (IND) approval from China's National Medic... -
NEOK002: Next-Generation Bispecific ADC Targeting EGFR and MUC1 Enters Clinical Development for Solid Tumors
Conference Coverage AACR USA Overview NEOK002 (formerly ABL209), a bispecific antibody-drug conjugate (ADC), has entered clinical development, designed to concurrently target two key cancer antigens, EGFR and MUC1, implicated in epitheli... -
BeOne Medicines’ BEQALZI™ (Sonrotoclax) Gains US FDA Approval for Relapsed/Refractory Mantle Cell Lymphoma as First BCL2 Inhibitor
Stock Titan USA Overview BeOne Medicines announced that BEQALZI™ (sonrotoclax) has received U.S. FDA approval for the treatment of relapsed/refractory Mantle Cell Lymphoma (MCL), marking it as the first BCL2 inhibitor for this indication... -
GSK’s Bepirovirsen for Chronic Hepatitis B Receives FDA Priority Review and Breakthrough Therapy Designation
GSK USA Overview GSK announced that its investigational antisense oligonucleotide (ASO), Bepirovirsen, a candidate for chronic Hepatitis B, has been granted both Priority Review and Breakthrough Therapy Designation (BTD) by the U.S. FDA.... -
FDA Grants Breakthrough Therapy Designation to Chronic Low Back Pain Treatment, Signaling Potential Shift for Cannabinoid-Derived Therapies
YouTube (CB1 Capital) USA Overview The U.S. FDA has granted Breakthrough Therapy Designation (BTD) for a treatment for chronic low back pain. This announcement potentially signals an emerging wave of designations for cannabinoid-derived ... -
Curanex Pharmaceuticals Reports Q1 2026 Progress, Phyto-N Advances Towards FDA IND Submission for Ulcerative Colitis and Pipeline Expands to Cancer Cachexia
Taiwan News Taiwan Overview US-based Curanex Pharmaceuticals provided a Q1 2026 update, focusing on its lead drug candidate, Phyto-N. The company is advancing Phyto-N towards a planned Investigational New Drug (IND) submission to the U.S...
