Antibodies

2 July 2023

SystImmune, Inc. Announces FDA Clearance of IND Application for BL-B01D1, a Bi-specific Antibody Drug Conjugate Targeting EGFR and HER3, Enabling Initiation of Phase 1 Clinical Trials in the U.S. for Metastatic or Unresectable Non-Small Cell Lung Cancer

1 July 2023

Cyltezo®, first and only FDA-approved Interchangeable biosimilar to Humira®, now commercially available in the U.S.

1 July 2023

Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator

1 July 2023

argenx and Zai Lab Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China

1 July 2023

Transcenta Presented PFS Data by CLDN18.2 Expression Level from Phase I/II Study of Osemitamab (TST001) plus CAPOX as the First-Line Treatment of Advanced G/GEJ Cancer at ESMO GI Annual Congress 2023

1 July 2023

Chime Biologics Announces Strategic Cooperation with Leads Biolabs and BeiGene to Advance LBL-007 mAb Development and Manufacturing Globally

1 July 2023

ESMO GI Data: Agenus’ Botensilimab/Balstilimab Combination Achieves Unprecedented Survival in Advanced Colorectal Cancer

1 July 2023

Sandoz to launch Hyrimoz® (adalimumab-adaz) high-concentration formulation, marking Sandoz entrance into US immunology space

1 July 2023

Alligator Bioscience Announces Positive Second Interim Efficacy Analysis from Mitazalimab OPTIMIZE-1 Phase 2 Study in 1st Line Pancreatic Cancer

30 June 2023

Eculizumab (Soliris) Biosimilars & Biosuperiors Pipeline Review

30 June 2023

Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)

30 June 2023

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%

30 June 2023

HaemaLogiX Announces Positive Final Results from KappaMab Combination Phase IIb Myeloma Trial

30 June 2023

Harbour BioMed Announces Biologics License Application Acceptance of Batoclimab for Treatment of Generalized Myasthenia Gravis by NMPA

30 June 2023

Immunome and Morphimmune Announce Definitive Merger Agreement and Simultaneous Private Placement Investment of $125 Million to Develop Targeted Cancer Therapies

30 June 2023

Imfinzi plus Imjudo demonstrated sustained overall survival benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA Phase III trial

29 June 2023

BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC

29 June 2023

Domain Therapeutics announces nomination of best-in-class CCR8 antibody candidate, DT-7012, further strengthening its unique portfolio of GPCR-targeting immunotherapies

29 June 2023

Aflibercept 8 mg in diabetic macular edema first to achieve sustained vision gains with up to 83% of patients extended to 16-24 weeks at two years

28 June 2023

Henlius Immune Checkpoints Inhibitor Anti-CTLA-4 mAb Received IND Approval for the Treatment of HCC

28 June 2023

Inozyme Pharma Announces Dosing of First Infant with ENPP1 Deficiency in a Phase 1b Trial of INZ-701

28 June 2023

Two-year Results for Aflibercept 8 mg from Pivotal PHOTON Trial Demonstrate Durable Vision Gains at Extended Dosing Intervals in Diabetic Macular Edema

28 June 2023

ImmunoGenesis and Cancer Focus Fund Announce $4.5 Million Investment to Support First-in-Human Trial of IMGS-001 for Relapsed or Refractory Advanced Solid Tumors

28 June 2023

Genmab and AbbVie Announce Positive Topline Results from Phase 1/2 EPCORE™ NHL-1 Trial Evaluating Epcoritamab (DuoBody® CD3xCD20) in Patients with Relapsed/Refractory Follicular Lymphoma (FL)

27 June 2023

Xentria and Meitheal Pharmaceuticals Announce Exclusive Licensing Agreement for XTMAB-16 in North America

27 June 2023

Press Release: Positive topline Phase 2b data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody

27 June 2023

New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

27 June 2023

UCB announces U.S. FDA approval of RYSTIGGO® (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis

26 June 2023

Avalo Announces Topline Data from Phase 2 PEAK Trial for AVTX-002 (quisovalimab) in Patients with Non-Eosinophilic Asthma

26 June 2023

FibroGen Announces Topline Results from Phase 3 ZEPHYRUS-1 Study of Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis

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