Drug

Company Drug

Hybio Pharma’s Generic Tirzepatide ANDA Accepted by FDA – First-to-File Challenger Targets $20B+ Dual GLP-1/GIP Agonist Franchise with Paragraph IV Certification

Shenzhen Hybio Pharmaceutical Co., Ltd. (SHE: 300199) announced today that the U.S. Food and Drug...

Company Drug

Roche Receives FDA Priority Review for Enspryng in Thyroid Eye Disease – IL-6 Inhibitor Leverages Novel Recycling Technology for Second Indication

Fineline Cube Jul 1, 2026

Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced today that the U.S. Food and Drug...

Company Drug

Huiyu Pharma Receives NMPA Clinical Trial Approval for HY-1016 Extended-Release Dienogest Injection – Novel Formulation Aims to Transform Endometriosis Treatment Adherence

Fineline Cube Jul 1, 2026

Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) announced today that it has received clinical trial...

Company Drug

CSPC Innovation Launches Phase III Trial of SYS6010 ADC-PD-1 Combo in Resected NSCLC – Novel EGFR-Targeted Antibody-Drug Conjugate Enters Adjuvant Setting

Fineline Cube Jul 1, 2026

CSPC Innovation Pharmaceutical Co., Ltd. (SHE: 300765) announced today the initiation and public registration of...

Company Drug

Sanofi Reports Positive Phase 3 Baby-COMET Results for Nexviazyme in Infantile-Onset Pompe Disease – ERT Shows 100% Survival and Ventilation-Free Outcomes at 52 Weeks

Fineline Cube Jul 1, 2026

Sanofi S.A. (NASDAQ: SNY) announced today positive top-line results from the Baby-COMET Phase 3 study...

Company Drug

BeOne Medicines Reports 43% Reduction in Disease Progression with BRUKINSA-Rituximab Combo in Phase III MCL Study – Chemotherapy-Free Regimen Shows Significant PFS Benefit

Fineline Cube Jul 1, 2026

BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced today positive top-line results from...

Company Drug

Shanghai Bao Pharmaceuticals Secures NMPA IND Approval for BJ044 Recombinant Ulinastatin – First Synthetic Biology-Derived Therapy for Critical Care Indications

Fineline Cube Jun 30, 2026

Shanghai Bao Pharmaceuticals Co., Ltd. (HKG: 2659) announced that the National Medical Products Administration (NMPA)...

Company Drug

AbbVie and Genmab’s Epcoritamab-Lenalidomide Combination Achieves Primary Endpoint in Phase 3 DLBCL Trial – 60% Reduction in Progression/Death Risk vs Standard R-GemOx

Fineline Cube Jun 30, 2026

AbbVie (NYSE: ABBV) announced positive topline results from the Phase 3 EPCORE DLBCL-4 trial, demonstrating...

Company Drug

Hua Medicine Completes Greater China Rollout as Dorzagliatin Gains Macau Approval – First-in-Class Glucokinase Activator Now Available Across All Chinese Territories

Fineline Cube Jun 30, 2026

Hua Medicine (HKG: 2552) announced that the Pharmaceutical Administration Bureau of the Macau Special Administrative...

Company Drug

AbbVie’s SKYRIZI Wins FDA Approval for Pediatric Psoriasis, Expanding IL-23 Blocker to Children Six and Older

Fineline Cube Jun 29, 2026

AbbVie (NYSE: ABBV) announced on June 26, 2026, that the U.S. Food and Drug Administration...

Company Drug

Akeso Biopharma Ships First Batch of Gumokimab for Psoriasis Following NMPA Approval

Fineline Cube Jun 29, 2026

Akeso Biopharma (HKG: 9926) announced on June 26, 2026, that Qiyoukang (gumokimab, AK111) has completed...

Company Drug

Eli Lilly’s Jaypirca Wins CHMP Recommendation for All-Line CLL Treatment Regardless of Prior BTK Inhibitor Use

Fineline Cube Jun 29, 2026

Eli Lilly and Company (NYSE: LLY) announced on June 26, 2026, that the European Medicines...

Company Drug

J&J’s TECVAYLI-Daratumumab Combo Receives CHMP Recommendation for Earlier Multiple Myeloma Treatment Line

Fineline Cube Jun 29, 2026

Johnson & Johnson (J&J, NYSE: JNJ) announced on June 26, 2026, that the Committee for...

Company Drug

Mabwell Bioscience Secures NMPA Approval for 9MW5211 Clinical Trial in Multiple Sclerosis – Expanding Autoimmune Pipeline

Fineline Cube Jun 25, 2026

Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced that China’s National Medical Products Administration (NMPA)...

Company Drug

Takeda Secures NMPA Approval for Adzynma – China’s First Recombinant ADAMTS13 Therapy for Congenital TTP

Fineline Cube Jun 25, 2026

Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that China’s National Medical Products Administration...

Company Drug

Gilead’s Trodelvy (Sacituzumab Govitecan) Secures European Commission Approval for First-Line Metastatic TNBC – Expanding ADC Access to Treatment-Naïve Patients

Fineline Cube Jun 25, 2026

Gilead Sciences, Inc. (NASDAQ: GILD) announced that the European Commission (EC) has granted marketing authorization...

Company Drug

Henlius and Organon Canada Launch Denosumab Biosimilars BILDYOS and TUZEMTY – Expanding Access to Bone-Targeted Therapies Across All Canadian Indications

Fineline Cube Jun 25, 2026

Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon Canada announced the official commercial launch of...

Company Drug

AbbVie’s SKYRIZI (Risankizumab) Secures European Commission Approval for Pediatric Plaque Psoriasis – First IL-23 Inhibitor Authorized for Children as Young as Six

Fineline Cube Jun 25, 2026

AbbVie Inc. (NYSE: ABBV) announced that the European Commission (EC) has granted marketing authorization for...

Company Drug

Sanofi’s Wayrilz (Rilzabrutinib) Secures Japanese Approval for Immune Thrombocytopenia – Expanding Global Footprint Across Six Major Markets

Fineline Cube Jun 24, 2026

Sanofi S.A. (NASDAQ: SNY) announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved...

Company Drug

Mabwell Secures NMPA Clinical Trial Approval for 6MW5311 Bispecific Antibody – Dual US-China Authorization for Hematological Malignancies

Fineline Cube Jun 24, 2026

Mabwell Bioscience Co., Ltd. (HKG: 2493) announced that China’s National Medical Products Administration (NMPA) has...

Drug

Hybio Pharma’s Generic Tirzepatide ANDA Accepted by FDA – First-to-File Challenger Targets $20B+ Dual GLP-1/GIP Agonist Franchise with Paragraph IV Certification

Roche Receives FDA Priority Review for Enspryng in Thyroid Eye Disease – IL-6 Inhibitor Leverages Novel Recycling Technology for Second Indication

Huiyu Pharma Receives NMPA Clinical Trial Approval for HY-1016 Extended-Release Dienogest Injection – Novel Formulation Aims to Transform Endometriosis Treatment Adherence

CSPC Innovation Launches Phase III Trial of SYS6010 ADC-PD-1 Combo in Resected NSCLC – Novel EGFR-Targeted Antibody-Drug Conjugate Enters Adjuvant Setting

Sanofi Reports Positive Phase 3 Baby-COMET Results for Nexviazyme in Infantile-Onset Pompe Disease – ERT Shows 100% Survival and Ventilation-Free Outcomes at 52 Weeks

BeOne Medicines Reports 43% Reduction in Disease Progression with BRUKINSA-Rituximab Combo in Phase III MCL Study – Chemotherapy-Free Regimen Shows Significant PFS Benefit

Shanghai Bao Pharmaceuticals Secures NMPA IND Approval for BJ044 Recombinant Ulinastatin – First Synthetic Biology-Derived Therapy for Critical Care Indications

AbbVie and Genmab’s Epcoritamab-Lenalidomide Combination Achieves Primary Endpoint in Phase 3 DLBCL Trial – 60% Reduction in Progression/Death Risk vs Standard R-GemOx

Hua Medicine Completes Greater China Rollout as Dorzagliatin Gains Macau Approval – First-in-Class Glucokinase Activator Now Available Across All Chinese Territories

AbbVie’s SKYRIZI Wins FDA Approval for Pediatric Psoriasis, Expanding IL-23 Blocker to Children Six and Older

Akeso Biopharma Ships First Batch of Gumokimab for Psoriasis Following NMPA Approval

Eli Lilly’s Jaypirca Wins CHMP Recommendation for All-Line CLL Treatment Regardless of Prior BTK Inhibitor Use

J&J’s TECVAYLI-Daratumumab Combo Receives CHMP Recommendation for Earlier Multiple Myeloma Treatment Line

Mabwell Bioscience Secures NMPA Approval for 9MW5211 Clinical Trial in Multiple Sclerosis – Expanding Autoimmune Pipeline

Takeda Secures NMPA Approval for Adzynma – China’s First Recombinant ADAMTS13 Therapy for Congenital TTP

Gilead’s Trodelvy (Sacituzumab Govitecan) Secures European Commission Approval for First-Line Metastatic TNBC – Expanding ADC Access to Treatment-Naïve Patients

Henlius and Organon Canada Launch Denosumab Biosimilars BILDYOS and TUZEMTY – Expanding Access to Bone-Targeted Therapies Across All Canadian Indications

AbbVie’s SKYRIZI (Risankizumab) Secures European Commission Approval for Pediatric Plaque Psoriasis – First IL-23 Inhibitor Authorized for Children as Young as Six

Sanofi’s Wayrilz (Rilzabrutinib) Secures Japanese Approval for Immune Thrombocytopenia – Expanding Global Footprint Across Six Major Markets

Mabwell Secures NMPA Clinical Trial Approval for 6MW5311 Bispecific Antibody – Dual US-China Authorization for Hematological Malignancies

You Missed

Hybio Pharma’s Generic Tirzepatide ANDA Accepted by FDA – First-to-File Challenger Targets $20B+ Dual GLP-1/GIP Agonist Franchise with Paragraph IV Certification

Roche Receives FDA Priority Review for Enspryng in Thyroid Eye Disease – IL-6 Inhibitor Leverages Novel Recycling Technology for Second Indication

Huiyu Pharma Receives NMPA Clinical Trial Approval for HY-1016 Extended-Release Dienogest Injection – Novel Formulation Aims to Transform Endometriosis Treatment Adherence

RaysightMed Secures Nearly RMB 100 Million in Strategic Financing Led by State-Owned Capital – Accelerates Cardiovascular Diagnostics Scale-Up and AI Surgical Robotics Development