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