Antibodies

09 Jul 2020 Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease
08 Jul 2020 Merck and Eisai Receive Complete Response Letter for KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination as First-Line Treatment for Unresectable Hepatocellular Carcinoma
07 Jul 2020 In Fight Against COVID-19, CSL Behring Begins Trial to Evaluate Monoclonal Antibody (CSL312) for Respiratory Distress
07 Jul 2020 Byondis’ Investigational Antibody-Drug Conjugate SYD985 Selected for I-SPY 2 TRIAL™ in Early-Stage Breast Cancer
06 Jul 2020 Immunomedics Announces Positive Results from Phase 3 ASCENT Study of TRODELVY™ in Previously-Treated Patients with Metastatic Triple-Negative Breast Cancer (mTNBC)
06 Jul 2020 Regeneron Announces Start of REGN-COV2 Phase 3 COVID-19 Prevention Trial in Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
06 Jul 2020 ADC Therapeutics Announces U.S. Food and Drug Administration Has Lifted Partial Clinical Hold on Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine
06 Jul 2020 EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer
03 Jul 2020 Regeneron and Sanofi Provide Update on Kevzara® (sarilumab) Phase 3 U.S. Trial in COVID-19 Patients
02 Jul 2020 Sandoz reviewing options after Federal Circuit upholds lower court ruling in biosimilar Erelzi® case
01 Jul 2020 Transcenta Announces First Patient Dosed in Phase I Clinical Trial of Claudin18.2 Targeting Monoclonal Antibody TST001 in the US
01 Jul 2020 Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA
01 Jul 2020 FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma
30 Jun 2020 BioInvent submits a CTA for a Phase I/IIa trial of BI-1808, a first-in-class anti-TNFR2 antibody for the treatment of patients with solid tumors and CTCL
30 Jun 2020 Chugai’s Enspryng (Satraliazumab) Subcutaneous Injection 120 mg Syringe Approved in Japan for Neuromyelitis Optica Spectrum Disorder
30 Jun 2020 Seattle Genetics Announces Positive Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
30 Jun 2020 FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
30 Jun 2020 FDA Approves Genentech’s Phesgo (Fixed-Dose Combination of Perjeta and Herceptin for Subcutaneous Injection) for HER2-Positive Breast Cancer
29 Jun 2020 Kiniksa Announces Positive Data from Phase 3 Trial of Rilonacept in Recurrent Pericarditis (RHAPSODY)
29 Jun 2020 ULTOMIRIS® (ravulizumab) Receives Marketing Authorization from European Commission for Adults and Children with Atypical Hemolytic Uremic Syndrome (aHUS)
28 Jun 2020 Samsung Bioepis Receives Positive CHMP Opinion for AYBINTIO® (Bevacizumab)
28 Jun 2020 Novartis receives positive CHMP opinion for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps
28 Jun 2020 Novartis Cosentyx® gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile
28 Jun 2020 Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus
28 Jun 2020 European Commission Approves Reblozyl (luspatercept) for the Treatment of Transfusion-Dependent Anemia in Adult Patients with Myelodysplastic Syndromes or Beta Thalassemia

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