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23 Jan 2019 TG Therapeutics Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Umbralisib for the Treatment of Marginal Zone Lymphoma
23 Jan 2019 Cocrystal Pharma Provides Update on Clinical Development Program Evaluating CC-31244 for Ultra-Short Treatment of Hepatitis C Virus
23 Jan 2019 Attune Pharmaceuticals Announces Positive Phase 1 Results for ATN-249, an Oral Plasma Kallikrein Inhibitor for the Treatment of HAE
23 Jan 2019 Ultragenyx Announces Positive Topline Data from Ongoing Long-Term Extension Study of UX007 for the Treatment of Long-chain Fatty Acid Oxidation Disorders
23 Jan 2019 Genmab Announces Initiation of U.S. FDA Regulatory Submission for Label Expansion of Daratumumab in Combination with Lenalidomide and Dexamethasone in Front Line Multiple Myeloma
23 Jan 2019 U.S. FDA Accepts sNDAs for PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate)
23 Jan 2019 Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease
23 Jan 2019 European Commission Approves BLINCYTO® (blinatumomab) In Patients With Philadelphia Chromosome Negative Minimal Residual Disease-Positive B-cell Precursor Acute Lymphoblastic Leukemia
23 Jan 2019 Immunochina Raises $20.4 Million USD in Series C Financing
23 Jan 2019 Aurinia Announces Voclosporin Ophthalmic Solution Demonstrates Statistically Superior Efficacy Versus Restasis® in a Phase 2 Head-to-Head Study for the Treatment of Dry Eye Syndrome
23 Jan 2019 Translate Bio Announces FDA Clinical Hold on Investigational New Drug Application (IND) for MRT5201 for the Treatment of Ornithine Transcarbamylase (OTC) Deficiency
21 Jan 2019 BerGenBio Announces Start of Phase I Trial Evaluating ADCT-601, a Novel Anti-AXL ADC, in Patients With Advanced Solid Tumours
21 Jan 2019 Center for Beta Cell Therapy in Diabetes and ViaCyte Announce Start of European Clinical Trial of Human Stem Cell-derived Implants in Type 1 Diabetes Patients
21 Jan 2019 Nash Pharmaceuticals Announces 84% Reduction of Fibrosis by Additional Lead Compound In Second Pre-Clinical Study For Non-Alcoholic Fatty Liver Disease
21 Jan 2019 Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
21 Jan 2019 ISA Pharmaceuticals Announces Start of Phase 2 Combination Trial of ISA101b and Regeneron’s Cemiplimab in Oropharyngeal Cancer
21 Jan 2019 US FDA Approves ONTRUZANT® (trastuzumab-dttb), Samsung Bioepis’ First Oncology Medicine in the United States
19 Jan 2019 Kyn Therapeutics Enters into Global Strategic Collaboration with Celgene to Develop Immuno-oncology Therapies
19 Jan 2019 AVROBIO, Inc. Announces Acceptance of Investigational New Drug (IND) Application for Investigator-Sponsored Phase 1/2 Clinical Trial for AVR-RD-04 Gene Therapy for Cystinosis
19 Jan 2019 TYME’s Novel Metabolic-Based Cancer Therapy, SM-88, Improves Survival in Phase II Study of Patients with Advanced Pancreatic Cancer

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