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Tag Archives: FDA

Koutif Therapeutics Announces FDA Acceptance of IND Application for Novel New Treatment of IBD

Wednesday, February 20th 2019 at 4:00pm UTC CLEVELAND–(BUSINESS WIRE)– Koutif Therapeutics today announced that its investigational new drug (IND) application for KT-1002 has been cleared by the US Food and Drug Administration to begin a Phase 1 clinical trial for the treatment of inflammatory bowel disease (IBD), including ulcerative colitis …

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Ocular Therapeutix™ Announces Dosing of First Patient in OTX-TKI (tyrosine kinase inhibitor implant) Phase 1 Clinical Trial for the Treatment of Wet Age-related Macular Degeneration (AMD)

Wednesday, February 20th 2019 at 1:30pm UTC BEDFORD, Mass.–(BUSINESS WIRE)– Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the dosing of the first patient in a Phase 1 trial of OTX-TKI …

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Rocket Pharmaceuticals Announces Participation in Fireside Chat at the 8th Annual SVB Leerink Global Healthcare Conference

Wednesday, February 20th 2019 at 12:00pm UTC NEW YORK–(BUSINESS WIRE)– Rocket Pharmaceuticals, Inc. (Nasdaq: RCKT) (“Rocket”), a leading U.S.-based multi-platform gene therapy company, today announces that Gaurav Shah, M.D., Chief Executive Officer and President of Rocket, will participate in a fireside chat at the 8th Annual SVB Leerink Global Healthcare …

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) Monotherapy for Third-Line Treatment of Patients with Advanced Small Cell Lung Cancer (SCLC)

Wednesday, February 20th 2019 at 11:45am UTC Marks First Application for KEYTRUDA in SCLC KENILWORTH, N.J.–(BUSINESS WIRE)– Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License …

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Axonics® annonce les premiers résultats cliniques positifs de son étude pivot ARTISAN-SNM

Wednesday, February 20th 2019 at 10:23am UTC IRVINE, Californie–(BUSINESS WIRE)– Axonics Modulation Technologies, Inc. (NASDAQ : AXNX), une société de technologie médicale spécialisée dans le développement et la commercialisation de nouveaux dispositifs implantables de neuromodulation sacrée (« NMS ») pour le traitement des problèmes de dysfonctionnement urinaire et intestinal, a annoncé aujourd’hui les premiers résultats positifs issus …

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Pfizer Receives European Approval for ZIRABEV™ (bevacizumab), a Biosimilar to Avastin®*

Tuesday, February 19th 2019 at 2:32pm UTC NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) today announced the European Commission (EC) has approved ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic …

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Ophthotech Corporation to Report Fourth Quarter and Full Year 2018 Financial Results and Host Conference Call on Tuesday, February 26, 2019

Tuesday, February 19th 2019 at 1:00pm UTC NEW YORK–(BUSINESS WIRE)– Ophthotech Corporation (Nasdaq: OPHT) today announced that it will report its fourth quarter and full year 2018 financial and operating results on Tuesday, February 26, 2019. Following the announcement, Ophthotech’s management team will host a live conference call and webcast …

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QPharma Continues to Expand KOL Mapping and Targeting Footprint

Tuesday, February 19th 2019 at 1:00pm UTC Another Global Pharmaceutical Giant Joins Titanium® Client Roster MORRISTOWN, N.J.–(BUSINESS WIRE)– QPharma, a premier provider of commercial and compliance services to the life sciences industry, has been engaged by several new clients in 2019, including a Top 15 pharmaceutical manufacturer, to provide a …

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ARS Pharmaceuticals Announces FDA Fast Track Designation for ARS-1 Intranasal Epinephrine Spray

Tuesday, February 19th 2019 at 1:00pm UTC SAN DIEGO, Calif.–(BUSINESS WIRE)– ARS Pharmaceuticals, Inc., a pharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions potentially leading to anaphylaxis, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track …

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Alpine Immune Sciences Presents Preclinical ALPN-101 GvHD Data at the 2019 Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR (TCT Meetings)

Tuesday, February 19th 2019 at 12:00pm UTC Appoints Immunology Veteran Vijay Kuchroo, DVM, PhD to Scientific Advisory Board SEATTLE–(BUSINESS WIRE)– Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced it will present preclinical GvHD data from …

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