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

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

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

Innovent Biologics’ Picankibart Achieves Success in Phase III CLEAR-1 Study for Moderate to Severe Plaque Psoriasis

Innovent Biologics, picankibart, Phase III CLEAR-1 study, moderate to severe plaque psoriasis, IL-23p19 class, new drug application, Center for Drug Evaluation, National Medical Product Administration.

NS Pharma’s Viltepso Fails Confirmatory Phase III Trial for Duchenne Muscular Dystrophy Treatment

Viltepso, NS Pharma, Duchenne muscular dystrophy, RACER53 study, viltolarsen, FDA approval, confirmatory trial, phase III trial, DMD treatment

J&J Adjusts Dosing Strategy for Actinium Prostate Cancer Drug Following Early Study Setbacks

J&J, Johnson & Johnson, actinium prostate cancer drug, capped dosing, flexible dosing, patient deaths, early study, clinical trial, cancer treatment, drug development.

Revolutionizing Biotherapeutic Analysis: Novel icIEF Fractionation and Mass Spectrometry for Charge Characterization

biotherapeutics, icIEF fractionation, mass spectrometry, charge characterization, protein analysis, therapeutic proteins, biopharmaceuticals, analytical techniques, protein purification, protein separation, protein charge variants.

Tango Pauses Clinical Trials of Promising Solid Tumor Treatment Due to Liver Toxicity Concerns

Tango Therapeutics, solid tumor treatment, clinical trials, liver toxicity, drug development, cancer research, treatment side effects, patient safety.