Drug

Company Drug

AstraZeneca and Daiichi Sankyo’s ENHERTU Secures Dual FDA Approval for HER2-Positive Early Breast Cancer – Neoadjuvant and Adjuvant Indications Supported by Landmark Phase 3 Data

AstraZeneca (NYSE: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. Food and Drug...

Company Drug

Roche’s Tecentriq Secures FDA Approval for ctDNA-Guided Adjuvant Treatment in Muscle-Invasive Bladder Cancer – First MRD-Directed Immunotherapy with 41% Mortality Reduction

Fineline Cube May 18, 2026

Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration (FDA)...

Company Drug

Biogen’s Zorevunersen Receives China Breakthrough Therapy Designation for Dravet Syndrome – First ASO Targeting SCN1A Gene in Rare Epileptic Encephalopathy

Fineline Cube May 18, 2026

Biogen Inc. (NASDAQ: BIIB) announced that zorevunersen, an investigational antisense oligonucleotide (ASO) for Dravet syndrome,...

Company Drug

Shanghai CureGene’s CG-0255 Receives NMPA Clearance for Ischemic Stroke Clinical Trial – First Thiol-Based P2Y12 Inhibitor Overcoming Clopidogrel Resistance

Fineline Cube May 18, 2026

Shanghai CureGene Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...

Company Drug

Shenzhen Salubris Secures Chinese Approval for Xinfutai Plus – First Once-Weekly Teriparatide for High-Risk Postmenopausal Osteoporosis

Fineline Cube May 18, 2026

Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced market approval from China’s National Medical Products...

Company Drug

Changchun GeneScience’s GenSci161 Receives FDA Clearance for Hidradenitis Suppurativa Clinical Trial – Novel Bispecific Antibody Targeting IL-1α/IL-1β

Fineline Cube May 18, 2026

Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun...

Company Drug

Amgen’s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration

Fineline Cube May 15, 2026

Amgen Inc. (NASDAQ: AMGN) announced that China’s National Medical Products Administration (NMPA) has accepted for...

Company Drug

Chongqing Genrix Bio Receives NMPA Clinical Approval for GR1803 Bispecific Antibody in Relapsed/Refractory Multiple Myeloma

Fineline Cube May 15, 2026

Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) announced it has received clinical trial approval...

Company Drug

AstraZeneca Reports Positive Phase III VOLGA Interim Results for Imfinzi-Based Combinations in Muscle-Invasive Bladder Cancer

Fineline Cube May 15, 2026

AstraZeneca plc (NYSE: AZN) released high-level results from a prespecified interim analysis of the Phase...

Company Drug

Chipscreen Biosciences Secures Macao Market Approval for Bilessglu (Chiglitazar), Novel PPAR Pan-Agonist for Type 2 Diabetes

Fineline Cube May 15, 2026

Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced it has received marketing clearance from the Pharmaceutical...

Company Drug

Biogen Reports Positive Phase II CELIA Results for Diranersen, First-in-Class Tau-Targeting ASO Therapy in Early Alzheimer’s Disease

Fineline Cube May 15, 2026

Biogen Inc. (NASDAQ: BIIB) announced positive top-line results from the Phase II CELIA study, evaluating...

Company Drug

Hengrui Pharmaceuticals Secures NMPA Clinical Approval for RSS0393 Latex in Atopic Dermatitis Treatment

Fineline Cube May 15, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received clinical approval...

Company Drug

Sichuan Biokin Receives NMPA Go-Ahead for SI-B036 Bispecific Antibody Clinical Study in Advanced Solid Tumors

Fineline Cube May 15, 2026

Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that China’s National Medical Products Administration (NMPA)...

Company Drug

Hansoh Pharma Receives NMPA Approval for HS-10541 Phase I Trial – Category 1 KRAS G12C Inhibitor Targets Advanced Solid Tumors

Fineline Cube May 14, 2026

Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced it has received regulatory approval from China’s...

Company Drug

Pfizer’s Hympavzi Gains European Approval for Hemophilia with Inhibitors – Novel TFPI-Targeting Therapy Offers Weekly Subcutaneous Alternative to Factor Replacement

Fineline Cube May 14, 2026

Pfizer Inc. (NYSE: PFE) announced it has received European Commission (EC) approval for an indication...

Company Drug

Henlius Biotech Secures Australian TGA Approval for HLX48 Phase I Trial – Novel EGFR/c-Met Bispecific ADC Targets Advanced Solid Tumors

Fineline Cube May 14, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received regulatory approval from Australia’s Therapeutic...

Drug

Novo Nordisk’s Wegovy Shows 21.6% Weight Loss in Early Responders – OASIS 4 Subgroup Analysis Reveals Clinically Meaningful Benefits Across Patient Populations

Fineline Cube May 14, 2026

Novo Nordisk A/S (NYSE: NVO) presented new subgroup analyses from the Phase III OASIS 4...

Company Drug

Ab&b Bio-Tech Launches Phase I/II Trial of Recombinant RSV Vaccine – CHO Cell-Derived Adjuvanted Candidate Shows Enhanced Pre-F Protein Expression and Stability

Fineline Cube May 14, 2026

Ab&b Bio-Tech Co., Ltd. (HKG: 2627) announced the initiation of a Phase I/II clinical study...

Company Drug

Kanghong Pharma’s Gene Therapy KHN921 Receives FDA Approval for Hypertrophic Cardiomyopathy Trial – AAV9 Vector Targets MYBPC3 Mutations with Potential One-Time Treatment

Fineline Cube May 14, 2026

Chengdu Kanghong Pharmaceutical Group Co., Ltd. (SHE: 002773) announced that its subsidiary Chengdu Origen Biotechnology...

Company Drug

InnoCare Pharma Doses First Patient in ICP-054 (ZB021) Trial – Novel Oral IL-17AA/AF Inhibitor Shows Promise for Autoimmune Diseases

Fineline Cube May 14, 2026

InnoCare Pharma (HKG: 9969) announced the dosing of the first subject in a clinical study...

Drug

AstraZeneca and Daiichi Sankyo’s ENHERTU Secures Dual FDA Approval for HER2-Positive Early Breast Cancer – Neoadjuvant and Adjuvant Indications Supported by Landmark Phase 3 Data

Roche’s Tecentriq Secures FDA Approval for ctDNA-Guided Adjuvant Treatment in Muscle-Invasive Bladder Cancer – First MRD-Directed Immunotherapy with 41% Mortality Reduction

Biogen’s Zorevunersen Receives China Breakthrough Therapy Designation for Dravet Syndrome – First ASO Targeting SCN1A Gene in Rare Epileptic Encephalopathy

Shanghai CureGene’s CG-0255 Receives NMPA Clearance for Ischemic Stroke Clinical Trial – First Thiol-Based P2Y12 Inhibitor Overcoming Clopidogrel Resistance

Shenzhen Salubris Secures Chinese Approval for Xinfutai Plus – First Once-Weekly Teriparatide for High-Risk Postmenopausal Osteoporosis

Changchun GeneScience’s GenSci161 Receives FDA Clearance for Hidradenitis Suppurativa Clinical Trial – Novel Bispecific Antibody Targeting IL-1α/IL-1β

Amgen’s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration

Chongqing Genrix Bio Receives NMPA Clinical Approval for GR1803 Bispecific Antibody in Relapsed/Refractory Multiple Myeloma

AstraZeneca Reports Positive Phase III VOLGA Interim Results for Imfinzi-Based Combinations in Muscle-Invasive Bladder Cancer

Chipscreen Biosciences Secures Macao Market Approval for Bilessglu (Chiglitazar), Novel PPAR Pan-Agonist for Type 2 Diabetes

Biogen Reports Positive Phase II CELIA Results for Diranersen, First-in-Class Tau-Targeting ASO Therapy in Early Alzheimer’s Disease

Hengrui Pharmaceuticals Secures NMPA Clinical Approval for RSS0393 Latex in Atopic Dermatitis Treatment

Sichuan Biokin Receives NMPA Go-Ahead for SI-B036 Bispecific Antibody Clinical Study in Advanced Solid Tumors

Hansoh Pharma Receives NMPA Approval for HS-10541 Phase I Trial – Category 1 KRAS G12C Inhibitor Targets Advanced Solid Tumors

Pfizer’s Hympavzi Gains European Approval for Hemophilia with Inhibitors – Novel TFPI-Targeting Therapy Offers Weekly Subcutaneous Alternative to Factor Replacement

Henlius Biotech Secures Australian TGA Approval for HLX48 Phase I Trial – Novel EGFR/c-Met Bispecific ADC Targets Advanced Solid Tumors

Novo Nordisk’s Wegovy Shows 21.6% Weight Loss in Early Responders – OASIS 4 Subgroup Analysis Reveals Clinically Meaningful Benefits Across Patient Populations

Ab&b Bio-Tech Launches Phase I/II Trial of Recombinant RSV Vaccine – CHO Cell-Derived Adjuvanted Candidate Shows Enhanced Pre-F Protein Expression and Stability

Kanghong Pharma’s Gene Therapy KHN921 Receives FDA Approval for Hypertrophic Cardiomyopathy Trial – AAV9 Vector Targets MYBPC3 Mutations with Potential One-Time Treatment

InnoCare Pharma Doses First Patient in ICP-054 (ZB021) Trial – Novel Oral IL-17AA/AF Inhibitor Shows Promise for Autoimmune Diseases

You Missed

CBC Group and Global Healthcare Opportunities Merge to Create $21 Billion Healthcare Investment Colossus

Sanofi’s Efdoralprin Alfa Demonstrates Superior fAAT Normalization in Alpha-1 Antitrypsin Deficiency Phase II ElevAATe Study

Takeda Faces $885M Antitrust Verdict in Amitiza “Pay-for-Delay” Litigation; Damages to be Trebled Under U.S. Law

Novartis’ Pluvicto Demonstrates Significant PSA Response Improvement in PSMA-Positive mHSPC Patients in PSMAddition Study