Antibodies

31 Jan 2023 Amjevita™ (adalimumab-atto), first biosimilar to Humira®, now available in the United States
31 Jan 2023 Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Clinical Trial in Naïve aHUS Patients (Rare Disease)
31 Jan 2023 AmMax Bio Announces First Patients Dosed in Phase 2b Study of AMB-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)
31 Jan 2023 Deka Biosciences Receives FDA Clearance of DK210 (EGFR) Investigational New Drug Application
30 Jan 2023 TROPION-Lung07 Phase 3 Trial Initiated to Evaluate Datopotamab Deruxtecan in Combination with Pembrolizumab in Patients with Previously Untreated Metastatic Non-Small Cell Lung Cancer
30 Jan 2023 Spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares
30 Jan 2023 Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Eosinophilic Esophagitis
27 Jan 2023 FDA Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)
27 Jan 2023 Novartis provides update on Phase III STAND trial assessing crizanlizumab
27 Jan 2023 CytomX Therapeutics Announces Milestone Achievement in Probody® T-Cell Engaging Bispecific (TCB) Collaboration with Astellas
27 Jan 2023 Centessa Pharmaceuticals Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of LB101, First LockBody® Candidate, for Solid Tumors
27 Jan 2023 Update on US Food and Drug Administration Emergency Use Authorisation of Evusheld
27 Jan 2023 Aridis Reports Top-Line Results of the Phase 3 Double-Blinded, Superiority Trial of AR-301 For the Treatment of Staphylococcus aureus Ventilator Associated Pneumonia (VAP)
27 Jan 2023 Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency
26 Jan 2023 Magenta Therapeutics Voluntarily Pauses the MGTA-117 Phase 1/2 Dose-Escalation Clinical Trial to Investigate Drug Safety
26 Jan 2023 Mersana Therapeutics Announces Initiation of Phase 1 Trial of XMT-2056 in HER2-Expressing Tumors
26 Jan 2023 Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer
25 Jan 2023 Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy in First-Line Advanced or Unresectable Biliary Tract Cancer in KEYNOTE-966 Trial
25 Jan 2023 Merck Announces KEYNOTE-991 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Enzalutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer to Stop for Futility
24 Jan 2023 Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for CLN-978, a Novel T-Cell Engager for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
24 Jan 2023 Amolyt Pharma Announces Research Agreement and Licensing Option with XOMA
24 Jan 2023 AltruBio Announces First Patient Dosed in Phase 1 Trial of Next-Generation Immune Checkpoint Enhancer ALTB-268 for the Treatment of Ulcerative Colitis
24 Jan 2023 Memo Therapeutics AG Announces Positive Phase I Data with AntiBKV for Treatment of BKV Infection in Renal Transplant Patients
23 Jan 2023 Disc Medicine Announces Exclusive Licensing Agreement with Mabwell Therapeutics for Novel Anti-TMPRSS6 Monoclonal Antibodies to Modulate Iron Homeostasis
20 Jan 2023 Summit Therapeutics Closes Deal with Akeso Inc. to In-License Breakthrough Innovative Bispecific Antibody

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