United States Food and Drug Administration
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
Neumora Therapeutics’ Schizophrenia Drug NMRA-266 Faces FDA Hold Over Convulsions in Rabbits
Neumora, United States Food and Drug Administration, NMRA-266, Seizures, Schizophrenia
AstraZeneca’s FASENRA Gains FDA Approval for Add-On Maintenance Treatment of Severe Asthma in Children Aged 6-11
AstraZeneca, FASENRA, Benralizumab, Severe Asthma, Pediatric Label Expansion, FDA Approval, Children Aged 6-11
FDA Approves BrainStorm’s Phase IIIb Trial Design for NurOwn in Early-Stage ALS
BrainStorm Cell Therapeutics, NurOwn, Phase IIIb trial, Special Protocol Assessment (SPA), FDA agreement, Early-stage ALS, Amyotrophic Lateral Sclerosis (ALS)