Regulatory Affairs

      Adicet Bio Receives FDA Fast Track Designation for ADI-270 in Metastatic/Advanced Clear Cell Renal Cell Carcinoma

      REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta...

      Signet Therapeutics Announces IND Approval by the FDA for World’s First Targeted Therapy for Diffuse Gastric Cancer

      BOSTON--(BUSINESS WIRE)--Signet Therapeutics, a biotech company using organoid disease models and AI to advance targeted cancer therapy, today announced that the...

      U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for AKEEGA® (niraparib and abiraterone acetate) for Patients with BRCA-Positive Metastatic...

      BOSTON--(BUSINESS WIRE)--Foundation Medicine announced it has received approval from the FDA for FoundationOne®Liquid CDx to be used as a companion diagnostic...

      KaliVir Immunotherapeutics Announces FDA Clearance of Investigational New Drug (IND) for Oncolytic Immunotherapy VET3-TGI for Solid Tumors

      PITTSBURGH--(BUSINESS WIRE)--KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced that the FDA has cleared...

      Longboard Pharmaceuticals Receives Breakthrough Therapy Designation for Bexicaserin (LP352)

      LA JOLLA, Calif.--(BUSINESS WIRE)---- $LBPH #Epilepsy--Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for...

      Merck Receives Positive EU CHMP Opinion for WINREVAIR™ (sotatercept) in Pulmonary Arterial Hypertension (PAH)

      RAHWAY, N.J.--(BUSINESS WIRE)---- $MRK #MRK--Merck Receives Positive EU CHMP Opinion for WINREVAIR™ (sotatercept) in Pulmonary Arterial Hypertension (PAH)...

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