Antibodies

16 Jul 2019 FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101)
16 Jul 2019 SurgiMab Advances SGM-101, a Novel Fluorescent Tumor-specific Antibody, Into Pivotal Phase 3 Clinical Trial to Improve Surgical Outcomes in Colorectal Cancer Patients
13 Jul 2019 Janssen Submits Application to U.S. FDA Seeking Approval of New DARZALEX® (daratumumab) Subcutaneous Formulation
10 Jul 2019 FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
09 Jul 2019 FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications
08 Jul 2019 Y-mAbs Announces Successful Pre-BLA Meeting with FDA for Naxitamab
08 Jul 2019 Compass Therapeutics Announces First Patient Dosed in Phase 1 Trial of CTX-471
08 Jul 2019 Prestige BioPharma Releases Positive Results from Phase I Study of HD204, Biosimilar Candidate to Bevacizumab
08 Jul 2019 Concizumab phase 2 data demonstrate its potential as a safe and efficacious subcutaneous prophylaxis treatment for all patients with haemophilia
07 Jul 2019 Positive Data from Completed Phase 1/2a study of BIVV001 Presented at ISTH 2019
05 Jul 2019 GamaMabs Pharma announces presentation of murlentamab phase 2 study results in colorectal cancer at ESMO World Congress on Gastrointestinal Cancer
04 Jul 2019 Grifols Announces FDA Approval of Xembify®, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies
04 Jul 2019 ULTOMIRIS® (ravulizumab) Receives Marketing Authorization from European Commission for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
04 Jul 2019 BioInvent Receives Milestone Payment Related to TAK-169 Investigational New Drug Application
03 Jul 2019 GSK announces phase III start for its anti GM-CSF antibody, otilimab, in patients with rheumatoid arthritis (RA)
02 Jul 2019 Incyte and Zai Lab Announce Collaboration and License Agreement for INCMGA0012 in Greater China
02 Jul 2019 Bioinvent Receives Ind Approval For Phase I/IIa Trial of Anti-FcγRIIb Antibody
01 Jul 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer
01 Jul 2019 Menarini Ricerche Announces Publication of Pre-clinical Data of the First-in-class Antibody-drug Conjugate MEN1309/OBT076, Currently in Phase I Clinical Development
01 Jul 2019 Libtayo® (cemiplimab) Approved for Advanced Cutaneous Squamous Cell Carcinoma in the European Union
01 Jul 2019 Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV™ (bevacizumab-bvzr)
28 Jun 2019 CHMP Recommends Approval of Dupixent® (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents
28 Jun 2019 Amgen and UCB Provide Regulatory Update on Status of EVENITY™ (romosozumab) in the EU
28 Jun 2019 New report: Bispecific Antibodies for Immuno-Oncology & Other Diseases
27 Jun 2019 Genmab Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Lenalidomide and Dexamethasone in Frontline Multiple Myeloma

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