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Forxiga Approved in the EU for the Treatment of Symptomatic Chronic Heart Failure
Wednesday, February 08, 2023Forxiga dapagliflozin approved in the European Union to extend the indication for heart failure HF with reduced ejection fraction HFrEF to cover patients across the full spectrum of left ventricular ejection fraction LVEF including HF with mildly red...
Kiora Pharmaceuticals Receives Investigational New Drug Approval for Phase 2 Study of KIO-101
Wednesday, February 08, 2023Kiora Pharmaceuticals announced that it has received investigational new drug application approval for a Phase study of KIO for the treatment of the Ocular Presentation of Rheumatoid Arthritis and other autoimmune diseases OPRA This study will enrol...
Syneos Health and Haystack Health Partner to Accelerate Clinical Trials with AI
Wednesday, February 08, 2023Syneos Health announced a strategic partnership with Haystack Health to improve the identification and enrolment of patients for clinical trials The combination of Syneos Health with Haystack Health will more effectively and efficiently identify and...
Rocket Pharmaceuticals Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation
Wednesday, February 08, 2023Rocket Pharmaceuticals announced that the US Food and Drug Administration FDA has granted Regenerative Medicine Advanced Therapy RMAT designation to RPA the Companys investigational adenoassociated virus AAVbased gene therapy for the treatment of Dan...
Sensei Biotherapeutics Signs Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI)
Tuesday, February 07, 2023Sensei Biotherapeutics announced that it has signed a Cooperative Research and Development Agreement CRADA with the National Cancer Institute NCI part of the National Institutes of Health NIH to expand the development of SNS a conditionally active pH...
Ultima Genomics Announces Collaboration with 10x Genomics
Tuesday, February 07, 2023Ultima Genomics and x Genomics announced collaboration to integrate use of the x Genomics Chromium Single Cell Gene Expression solutions with Ultimas advanced ultrahigh throughput sequencing systems
Atreca and Xencor to Develop T-Cell Engaging Bispecific Antibody
Tuesday, February 07, 2023Atreca and Xencor as part of their existing strategic collaboration have mutually selected the first programme combining an Atrecadiscovered antibody with Xencors XmAb bispecific Fc domain and a cytotoxic Tcell binding domain CD Under the terms of c...
Sandoz Biologics Licence Application Accepted by US FDA for Biosimilar Denosumab
Monday, February 06, 2023Sandoz announced that the US Food and Drug Administration FDA has accepted its Biologics Licence Application BLA for proposed biosimilar denosumab The application includes all indications covered by the reference medicines Prolia denosumab and Xgeva...
Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application for Zuranolone
Monday, February 06, 2023Biogen announced the US Food and Drug Administration FDA has accepted the filing of a New Drug Application NDA for zuranolone in the treatment of major depressive disorder MDD and postpartum depression PPD Zuranolone is an investigational drug being...
U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer
Saturday, February 04, 2023Gilead Sciences announced the US Food and Drug Administration FDA has approved Trodelvy sacituzumab govitecanhziy for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor HRpositive human epidermal growth...
