Spruce Biosciences Appoints Dr. Jessica Cohen Pfeffer as Vice President of Clinical Development to Advance Rare Neurological Disease Pipeline Spruce Biosciences, Inc., a late-stage biopharmaceutical company dedicated to developing and commercializing innovative therapies for neurological disorders with significant unmet medical…
Korsana Biosciences Strengthens Executive Leadership as KRSA-028 Advances Toward Clinical Development for Alzheimer’s Disease Korsana Biosciences, Inc., a biotechnology company focused on discovering and developing innovative therapies for neurodegenerative disorders, has announced a series of strategic leadership appointments designed to…
Polpharma Biologics Advances PB016 as FDA and EMA Accept Biosimilar Applications for Review Polpharma Biologics International AG has announced a significant regulatory milestone with the acceptance of both its Biologics License Application (BLA) by the U.S. Food and Drug Administration…
Bayer Submits New Drug Application in China to Expand Finerenone Use for Adults with Non-Diabetic Chronic Kidney Disease Bayer has announced the submission of a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China’s National Medical…
EU Approval Positions Datroway® as the Only TROP2-Targeted Therapy with Overall Survival Benefit in First-Line Metastatic TNBC The European Commission (EC) has approved Datroway® (datopotamab deruxtecan) as a monotherapy for the first-line treatment of adults with unresectable or metastatic triple-negative…
Polpharma Biologics’ Vedolizumab Biosimilar PB016 Accepted for FDA and EMA Review, Advancing Access to Biologic Therapy for Inflammatory Bowel Disease Polpharma Biologics International AG has announced that its proposed vedolizumab biosimilar, PB016, has reached an important regulatory milestone after both…
Meitheal Pharmaceuticals Secures FDA Approval for Garzulys™ Biosimilar Insulin to Expand Diabetes Care in the U.S. Meitheal Pharmaceuticals, Inc., a Chicago-based biopharmaceutical company focused on the development and commercialization of generic injectable medicines, biologics, fertility therapies, and branded pharmaceutical products,…
Cofactor Genomics Appoints Renowned Oncologist Dr. Howard H. Bailey as Chief Medical Officer to Advance Precision Immunotherapy Diagnostics Cofactor Genomics, a commercial-stage diagnostics company focused on advancing precision oncology through RNA-based predictive testing, has announced the appointment of internationally recognized…
Teleflex Receives Historic FDA Approval for EZPLAZ™ Freeze Dried Plasma, Expanding Emergency Blood Transfusion Options Teleflex Incorporated, a global leader in medical technology and innovative healthcare solutions, has announced a landmark achievement with the U.S. Food and Drug Administration (FDA)…
Aqtual Strengthens Executive Leadership with Appointment of Daniil Kalyuzhny as Chief Financial Officer to Support Next Phase of Growth Aqtual, Inc., a precision medicine company pioneering active chromatin cell-free DNA (cfDNA) diagnostics, has announced the appointment of Daniil Kalyuzhny as…
Sarepta Therapeutics Appoints Michael Severino as Chief Executive Officer to Lead Next Phase of Precision Genetic Medicine Growth Sarepta Therapeutics, Inc., a global biotechnology company recognized for its leadership in precision genetic medicine for rare diseases, has announced the appointment…
Spruce Biosciences Strengthens Executive Leadership with Appointment of Rare Disease Expert as Chief Medical Officer Spruce Biosciences, Inc., a late-stage biopharmaceutical company dedicated to developing innovative therapies for neurological disorders with significant unmet medical need, has announced the appointment of…