Antibodies

1 July 2024

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

1 July 2024

FDA grants approval for Eylea biosimilar FYB203/AHZANTIVE (aflibercept-mrbb)

1 July 2024

Zydus and Dr. Reddy’s announce licensing agreement for co‐marketing of Pertuzumab biosimilar, a critical treatment for breast cancer patients in India

1 July 2024

FDA Approves PYZCHIVA® (ustekinumab-ttwe), Samsung Bioepis’ Biosimilar to Stelara

28 June 2024

KBio Announces FDA Clearance of IND Application for EV68-228-N for the Treatment of Acute Flaccid Myelitis and the First Patient Dosed in the Phase 1 Study

28 June 2024

RYBREVANT® (amivantamab) in combination with chemotherapy is the first therapy approved by the European Commission for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations

28 June 2024

GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-3650, an NK Cell Engager for Treatment of CD33+ Leukemia

28 June 2024

Elevation Oncology Announces Planned Combination Strategy for EO-3021 in Patients with Gastric or Gastroesophageal Junction Cancer

27 June 2024

AbbVie Acquires Celsius Therapeutics

27 June 2024

Bicara Therapeutics Reports Updated Interim Phase 1/1b Data of Ficerafusp Alfa (BCA101) in 1L HPV-negative Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

27 June 2024

Meitheal Pharmaceuticals Strengthens Biologics Portfolio with an Exclusive Commercial Licensing Agreement for YUSIMRY®, a Biosimilar of Humira®

27 June 2024

CASI Pharmaceuticals Announces Plan To Submit IND Application For CID-103, an Anti-CD 38 Antibody in Antibody-Mediated Rejection, and Receipt of a Non-Binding Proposal to Acquire Entire China Business of the Company

27 June 2024

Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer

27 June 2024

EPKINLY® (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

26 June 2024

Simcere Zaiming Announce Approval of Cetuximab Beta in China by the NMPA

26 June 2024

Star Therapeutics Presents Clinical Data for VGA039, a Subcutaneous Therapy for the Treatment of Von Willebrand Disease (VWD)

25 June 2024

CDR-Life Announces Pipeline Expansion of Highly Tumor-Targeted T Cell Engagers

25 June 2024

Update on ADJUVANT BR.31 Phase III trial of Imfinzi in non-small cell lung cancer

25 June 2024

Imfinzi demonstrated statistically significant and clinically meaningful improvement in event-free survival and overall survival for muscle-invasive bladder cancer in NIAGARA Phase III trial

25 June 2024

TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®, Approved in the European Union

25 June 2024

Evommune Secures Exclusive Rights to Develop and Commercialize a Phase 2-ready IL-18 targeted fusion protein from AprilBio

25 June 2024

Biond Biologics Announces First Patient Dosed with BND-35 in Phase 1 Clinical Trial

25 June 2024

EMA Approves Biocon Biologics’ New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites

25 June 2024

Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis

23 June 2024

Novo Nordisk A/S: Mim8 demonstrated superior reductions in annualised bleeding rate (ABR) compared to on-demand and prior prophylaxis treatment in people with haemophilia A

23 June 2024

Takeda Presents Late-Breaking Data from Phase 2b Study of Mezagitamab, Demonstrating Potential to Transform Treatment of Primary Immune Thrombocytopenia

22 June 2024

European Medicines Agency Validates Bristol Myers Squibb’s Application for Subcutaneous Nivolumab

22 June 2024

argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy

21 June 2024

āshibio Raises $40M in Seed and Series A Financing to Advance Therapies for Bone and Connective Tissue Disorders

21 June 2024

Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA® (guselkumab) for the treatment of moderately to severely active Crohn’s disease

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