Approved
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
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
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
AstraZeneca and Daiichi Sankyo’s Enhertu Wins Historic FDA Approval as First Tumor-Agnostic HER2-Directed Therapy
Enhertu, AstraZeneca, Daiichi Sankyo, FDA Approval, Tumor-Agnostic, HER2-Directed Therapy, Metastatic HER2-Positive Solid Tumors, Accelerated Approval, DESTINY-PanTumor02 Study, Objective Response Rate (ORR), Duration of Response (DoR)
Basilea Secures FDA Approval for Zevtera to Treat Three Types of Bacterial Infections
Basilea Pharmaceutica, Zevtera (ceftobiprole), FDA approval, Acute bacterial skin and skin structure infections (ABSSSI), Staphylococcus aureus bacteremia (SAB), Community-acquired bacterial pneumonia (CABP), Qualified Infectious Disease Product (QIDP) status, Priority Review/ Fast Track/ and QIDP designations, Ten years of exclusivity in the US
Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval
Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024
FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults
Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data
AstraZeneca’s Ultomiris Gains FDA Approval for Rare Autoimmune Condition – NMOSD
AstraZeneca, Ultomiris, ravulizumab-cwvz, FDA Approval, Rare Autoimmune Disease, Neuromyelitis Optica Spectrum Disorder (NMOSD), Long-acting C5 complement inhibitor, Phase 3 CHAMPION-NMOSD Trial, Reduced Relapse Rate, Dosing Frequency