Approved – Page 30

BMS Details Confirmatory Trial Win for KRAS Inhibitor Krazati

1 year ago talkbio0Tagged Accelerated, Approved, Confirmatory Trial, Inhibitor, K-ras Oncogene, KRAZATI, Myers, Non-Small Cell Lung Carcinoma, Pharmacotherapy, Progression-Free Survival, squibb, United States Food and Drug Administration

Bristol Myers Squibb, Krazati, KRAS inhibitor, confirmatory trial, non-small cell lung cancer (NSCLC), progression-free survival (PFS), chemotherapy, accelerated approval, FDA

Gilead’s Trodelvy Fails to Meet Primary Endpoint in Confirmatory Trial for Urothelial Cancer

1 year ago talkbio0Tagged Antibody-Drug Conjugates, Approved, Clinical Trials, Gilead Sciences, Neoplasms, Overall Survival, Trodelvy, TROPiCS-04 study, United States Food and Drug Administration, urothelial cancer

Gilead Sciences, Trodelvy, urothelial cancer, TROPiCS-04 study, overall survival, antibody-drug conjugate, oncology, clinical trials, FDA approval

FDA Delays Dupixent Decision for Uncontrolled COPD Treatment, EU Panel Recommends Approval

1 year ago talkbio0Tagged Approved, Chronic Obstructive Airway Disease, dupilumab, Dupixent, EU, Regeneron, sanofi, Uncontrolled, United States Food and Drug Administration

Dupixent, dupilumab, COPD, FDA, EU approval, Sanofi, Regeneron, uncontrolled COPD, treatment delay

FDA Approves Tris Pharma’s Onyda XR, First Liquid Non-Stimulant ADHD Medication for Pediatric Patients ###

1 year ago talkbio0Tagged Approved, Attention deficit hyperactivity disorder, clonidine, Extended Release Suspension, hydrochloride, Liquid medication, LiquiXR, Non-stimulant, Onyda, Pediatric brand name, Svalbard, Technology, Tris Pharma, United States Food and Drug Administration

Tris Pharma, Onyda XR, ADHD, Non-stimulant, Liquid medication, Pediatric patients, FDA approval, Clonidine hydrochloride, Extended-release oral suspension, LiquiXR technology

Regulatory Tracker: Lilly’s Retevmo Secures Pediatric Cancer FDA Nod ###

1 year ago talkbio0Tagged Accelerated, Approved, Eli, Eli Lilly, LIBRETTO-121 trial, Malignant Childhood Neoplasm, Malignant neoplasm of thyroid, RET-altered, Retevmo, selpercatinib, Solid Neoplasm, United States Food and Drug Administration

Retevmo, Eli Lilly, FDA approval, pediatric cancer, RET-altered, thyroid cancer, solid tumors, accelerated approval, LIBRETTO-121 trial, selpercatinib

FDA Approves Amgen’s Bkemv, First Interchangeable Biosimilar to Soliris for Rare Blood Disorders ###

1 year ago talkbio0Tagged Alexion, amgen, Approved, AstraZeneca, Atypical, Atypical Hemolytic Uremic Syndrome, Biosimilars, Bkemv, Hemolytic-Uremic Syndrome, Infrequent, interchangeable, Paroxysmal, Paroxysmal nocturnal hemoglobinuria, PNH, Soliris, United States Food and Drug Administration

Bkemv, Soliris, FDA approval, Interchangeable biosimilar, Rare blood disorders, Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS), Amgen, AstraZeneca, Alexion Pharmaceuticals

Amgen Secures FDA Approval for Bkemv, the First Interchangeable Biosimilar to Soliris for Rare Blood Disorders

1 year ago talkbio0Tagged amgen, Approved, Atypical, Atypical Hemolytic Uremic Syndrome, Biosimilars, Bkemv, Hematological Disease, Hemolytic-Uremic Syndrome, Infrequent, Paroxysmal, Paroxysmal nocturnal hemoglobinuria, PNH, Soliris, United States Food and Drug Administration

FDA approval, Amgen, Bkemv, Soliris, biosimilar, rare blood disorders, paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS)