02 Jan 2018 Selecta Biosciences Announces FDA Acceptance of Investigational New Drug Application for LMB-100 and SVP-Rapamycin Combination Therapy
02 Jan 2018 FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in Frontline Advanced Hodgkin Lymphoma
02 Jan 2018 BeiGene Initiates Global Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab in Patients with Hepatocellular Carcinoma
29 Dec 2017 CStone's anti-CTLA-4 antibody CS1002 filed for clinical trial approval in Australia
29 Dec 2017 Biocon and Mylan's Biosimilar Trastuzumab Receives Approval from ANVISA, Brazil Through their Partner Libbs
27 Dec 2017 CStone files CS1003, an anti-PD-1 antibody, for clinical trial approval in Australia
23 Dec 2017 Clover Biopharmaceuticals Receives CFDA Approval to Initiate Clinical Trials in China with Etanercept Biosimilar Candidate SCB-808
22 Dec 2017 First-in-Human Trial of New Immunotherapy Approach Shows Efficacy in Antibiotic Resistance
22 Dec 2017 FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma
22 Dec 2017 Adaptive Phase II Study of BAN2401 in Early Alzheimer’s Disease Continues toward 18-Month Endpoint
21 Dec 2017 JHL Biotech Submits Clinical Trial Application in Europe for Proposed Bevacizumab Biosimilar to Treat Colorectal, Lung, and Ovarian Cancers
21 Dec 2017 FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer
21 Dec 2017 Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease
20 Dec 2017 Trimodulin: concept for phase III study successfully coordinated with the authorities
20 Dec 2017 Bimekizumab demonstrates impressive joint and skin responses for psoriatic arthritis patients
20 Dec 2017 Samsung Bioepis' SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration
18 Dec 2017 FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program
18 Dec 2017 Aduro Biotech Announces the Initiation of a Phase 1/2 Clinical Trial of BION-1301, a Novel Anti-APRIL Antibody, for the Treatment of Multiple Myeloma
18 Dec 2017 Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Yervoy (ipilimumab) for the Treatment of Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma Bristol-Myers Squibb Receives Positive CHMP Opinion Recomm
18 Dec 2017 Apeiron Announces Publication of Clinical Data with Anti-GD2 Antibody Demonstrating Efficacy in Relapsed & Refractory High-Risk Neuroblastoma
16 Dec 2017 Celltrion Receives Positive CHMP Opinion for Herzuma® for Trastuzumab Biosimilar
16 Dec 2017 Ultragenyx and Kyowa Kirin Announce Burosumab Receives Positive CHMP Opinion for the Treatment of X-Linked Hypophosphatemia in Children
15 Dec 2017 Merck Provides Update on KEYNOTE-061, a Phase 3 Study of KEYTRUDA® (pembrolizumab) in Previously Treated Patients with Gastric or Gastroesophageal Junction Adenocarcinoma
14 Dec 2017 Complix Receives €0.5 Million Grant to Further Develop its Pipeline of Proprietary Cell Penetrating Alphabodies™ Against Intracellular Cancer Targets
14 Dec 2017 Izana Bioscience Launches as New Clinical-Stage Translational Medicine Company Developing Namilumab in Ankylosing Spondylitis

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