United States Food and Drug Administration
ImmunityBio’s Innovative IL-15 Superagonist Receives FDA Approval for Non-Muscle Invasive Bladder Cancer Treatment
ImmunityBio, FDA Approval, IL-15 Superagonist, Non-Muscle Invasive Bladder Cancer (NMIBC), Immunotherapy, Cancer Treatment
FDA Approves Takeda’s Subcutaneous Entyvio Injection for Maintenance Therapy in Moderate to Severe Crohn’s Disease
FDA, Takeda, Entyvio, Subcutaneous, Injection, Maintenance Therapy, Crohn’s Disease
Roche’s Alecensa Gains FDA Approval for Postsurgical Early Lung Cancer Treatment
Roche, Alecensa, FDA approval, Postsurgical treatment, Early lung cancer
AbbVie’s Rinvoq Leads Immunology Market as Physicians Rank Players, J&J Sees Decline
AbbVie, Rinvoq, Immunology players, Physicians’ ranking, J&J drop, Humira, Crohn’s disease, FDA approval, JAK inhibitor
Alecensa: FDA-Approved First ALK Inhibitor for Adjuvant Treatment in Early-Stage ALK-Positive NSCLC
Alecensa, ALK Inhibitor, Adjuvant Treatment, Early-Stage ALK-Positive NSCLC, FDA Approval, Genentech, Roche Group, ALINA Study, 76% Reduction in Disease Recurrence or Death, NCCN Guidelines
Vertex Initiates FDA Rolling Review for Non-Opioid Pain Medication Suzetrigine (VX-548)
Vertex Pharmaceuticals, Suzetrigine (VX-548), Non-opioid painkiller, FDA rolling review, Acute pain
FDA Grants De Novo Clearance to Scopio Labs’ AI-Powered Bone Marrow Pathology Application for Blood Disorders and Cancer
Scopio Labs, De Novo Clearance, FDA, Bone Marrow Pathology, AI, Blood Disorders, Cancer
Intra-Cellular’s Caplyta Triumphs in Major Depressive Disorder Phase 3 Trial, Edging Closer to FDA Filing
Intra-Cellular Therapies, Caplyta, Lumateperone, Major Depressive Disorder (MDD), Phase 3 Trial, Positive Results, Statistically Significant, Clinically Meaningful, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale for Severity of Illness (CGI-S), FDA Filing
FDA Launches CDER Center for Clinical Trial Innovation (C3TI) to Boost Trial Design and Efficiency
FDA, CDER (Center for Drug Evaluation and Research), C3TI (CDER Center for Clinical Trial Innovation), Clinical trial innovation, Efficiency, Drug development, Trial design, Collaboration
Novartis’ Fabhalta (Iptacopan) Receives FDA Priority Review for IgA Nephropathy (IgAN) Treatment
Novartis, Fabhalta, Iptacopan, IgA Nephropathy (IgAN), FDA Priority Review, Phase 3 Data