Antibodies

3 April 2025

Mabwell Announces NMPA Approval to Initiate Clinical Trial of novel B7-H3-targeting ADC for Advanced Solid Tumors in Combination with PD-1 Inhibitor

3 April 2025

Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II) and Positive Ongoing Interactions with FDA on DNL126 Through START Program

2 April 2025

Telix Announces First Patient Dosed in First-in-Human ZOLAR Trial of TLX300-CDx in Advanced Soft Tissue Sarcoma

2 April 2025

Hengrui’s Camrelizumab Combo Therapy Doubles the Five -Year Survival of Patients with Advanced Squamous Lung Cancer – A Potential Paradigm Shift in Clinical Outcome for this Difficult-to Treat Population

2 April 2025

Organon Acquires TOFIDENCE™ (tocilizumab-bavi), a Commercialized Biosimilar to ACTEMRA® (tocilizumab) Injection, for Intravenous Infusion in the U.S.

31 March 2025

Keros Therapeutics Announces Initial Topline Results from the Phase 1 Clinical Trial of KER-065 in Healthy Volunteers

31 March 2025

Radiance Announces FDA Clearance of IND Application for a Phase 1 Clinical Trial of RB-164™, an ROR-1 Targeted ADC, for Hematologic and Solid Malignancies

31 March 2025

Voyager Presents Robust Preclinical Data from Tau Targeting Gene Therapy and Antibody Programs at AD/PD™ 2025

31 March 2025

DESTINY-Gastric05 Phase 3 Trial of ENHERTU® Initiated in Patients with Previously Untreated HER2 Positive Advanced Gastric Cancer

31 March 2025

Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

31 March 2025

WINREVAIR™ (sotatercept-csrk) Reduced the Risk of a Composite of All-Cause Death, Lung Transplantation and Hospitalization for Pulmonary Arterial Hypertension (PAH) by 76% Compared to Placebo in the Phase 3 ZENITH Trial

31 March 2025

TIVDAK® (tisotumab vedotin) Approved by European Commission for Previously Treated Recurrent or Metastatic Cervical Cancer

31 March 2025

Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer

31 March 2025

SPARC announces submission of IND Application for SBO-154 to USFDA

28 March 2025

European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11

28 March 2025

Spyre Therapeutics Announces First Participant Dosed in Phase 1 Trial of SPY003, its Novel Half-life Extended IL-23 Antibody

28 March 2025

Richter Announces Submission to European Medicines Agency for Biosimilar Tocilizumab in Multiple Indications

27 March 2025

Actinium Pharmaceuticals Announces ATNM-400 a Novel Non-PSMA Targeting First in Class Prostate Cancer Radiotherapy Leveraging Actinium-225

27 March 2025

Bio-Thera and Dr. Reddy’s Execute Exclusive Commercialization Agreement for BAT2206, a Proposed Stelara® Biosimilar, and BAT2506, a Proposed Simponi® Biosimilar, for Southeast Asia

27 March 2025

Equillium Announces Results of the Phase 3 EQUATOR Study of Itolizumab in First-Line Treatment of Patients with Acute Graft-Versus-Host Disease

27 March 2025

Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) KEYTRUDA® (pembrolizumab) in Pivotal 3475A-D77 Trial

27 March 2025

Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement

27 March 2025

UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab)

26 March 2025

Bluejay Therapeutics Announces First Patient Dosed in AZURE-1 Global Pivotal Clinical Trial Evaluating Brelovitug (BJT-778) as a Monotherapy Treatment for Chronic Hepatitis D

26 March 2025

RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer

25 March 2025

FDA Grants Priority Review for Biologics License Application (BLA) and EMA Accepts Marketing Authorisation Application (MAA) for Apitegromab as a Treatment for Spinal Muscular Atrophy

25 March 2025

Helicore Biopharma Announces First Participant Dosed in Phase 1 Clinical Trial of HCR-188, a First-in-Class GIP Antagonist for the Treatment of Obesity

24 March 2025

Sungen Biomedical’s world-first new drug SGC001 monoclonal antibody receives FDA fast track approval

24 March 2025

Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for Platinum-resistant Ovarian Cancer

24 March 2025

CStone Submits Application to the European Medicines Agency for New Indication of Sugemalimab in Stage III Non-Small Cell Lung Cancer

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