FDA Approves Xpovio (Selinexor) for Multiple Myeloma
Nuclear export inhibitor indicated in combination with dexamethasone.
New Indication for Darzalex Approved by FDA
Now approved to be used in combiantion with lenalidomide and dexamethasone.
FDA Approves Avastin Biosimilar, Zirabev (Bvacizumab-bvzr), for Various Cancers
Bevacizumab-bvzr is an mAb endothelial growth factor biosimilar.
FDA Approves Soliris (Eculizumab) for Neuromyelitis Optica Spectrum Disorder
Complement inhibitor is the first treatment for the rare autoimmune disorder.
FDA Approves Dupixent (Dupilumab) for Chronic Rhinosinusitis
First treatment approved for the condition with nasal polyps.
FDA Approves New Somatuline Depot Syringe
New features to ease injection administration.
New Drug Review: Zulresso (Brexanolone)
The first drug approved to specifically treat post-partum depression.
FDA Expands Symdeko Indications
Approved to treat pediatric patients ages 6 years and older with cystic fibrosis
FDA Approves Victoza for Pediatric Type-2 Diabetes
First non-insulin drug for pediatric use approved in nearly 20 years.
FDA Approves Kanjinti for HER2 Cancers
Indications include breast cancer, metastatic gastric cancer, and metastatic gastroesophageal junction adenocarcinoma.
New Drug Review: Spravato
Both responder and remitter patients experienced a statistically significant longer time to relapse with esketamine compared to the placebo
FDA Approves Polivy for Large B-Cell Lymphoma
Drug targets the CD79b protein on B-cells.
FDA Approves Zerbaxa for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
Zerbaxa is a cephalosporin antibacterial and beta-lactamase inhibitor combination drug originally approved for abdominal and urinary tract infections.
FDA Approves First Drug to Treat Episodic Cluster Headaches in Adults
Patients on Emgality experienced an average of 8.7 fewer weekly episodic cluster headaches.
Lenalidomide Approved by FDA for Follicular and Marginal Zone Lymphoma
This thalidomide analogue is also indicated for multiple myeloma and myelodysplastic syndromes.
FDA Approves Vraylar (Cariprazine) for Bipolar Depression
New indication adds to the oral antipsychotic’s portfolio of conditions.
FDA Approves PI3K Inhibitors for Breast Cancer
First PIK3CA inhibitor treatment approved, along with diagnostic test.
New Gene Therapy for Pediatric Spinal Muscular Atrophy Approved by FDA
Zolgensma (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy
FDA Approves Sorilux (Calcipotriene) for Adolescent Plaque Psoriasis
Vitamin D analog foam indicated for topical treatment of plaque psoriasis in teens.
New Corlanor (Ivabradine) Formulation Approved by FDA
Oral solution now approved for adults and pediatric patients.
Generic VESIcare Tablets to Launch in U.S.
Update: now available from three manufacturers.
FDA Approves Nayzilam (Midazolam) for Seizure Activity in Patients with Epilepsy
Nayzilam is a benzodiazepine antiepileptic nasal spray.
FDA Approves Fragmin as First Pediatric Anticoagulant Treatment
Fragmin, a low-molecular-weight heparin dalteparin sodium injection, was approved for symptomatic venous thromboembolism.
FDA Approves Expanded Indication for Venetoclax
Venetoclax, a BCL-2 inhibitor first approved in 2016, is now indicated for chronic lymphocytic leukemia and small lymphocytic lymphoma.
Bavencio (Avelumab), Inlyta (Axitinib) Combination Approved for Advanced Renal Cell Carcinoma by FDA
Approval marks the first anti-PD-L1 therapy combination for RCC.
Ruzurgi (Amifampridine) Approved for Rare Pediatric Autoimmune Disorder
Ruzurgi approval for rare autoimmune disorder may be an olive branch.
Kadcyla Indication Expands as Adjuvant Breast Cancer Treatment
Recent trial shows greater invasive disease-free survival when treated with Kadcyla , (ado-trastuzumab emtansine)
Qternmet XR Combinations Approved for Type-2 Diabetes
New drug combines dapagliflozin, saxagliptin, and metformin.
Two Drugs Approved for Cardiomyopathy Caused by Amyloidosis
Two different versions of tafamadis get the FDA’s nod to treat a rare heart disease.
Tibsovo Indication Expanded to Newly-Diagnosed Acute Myeloid Leukemia by FDA
Tibsovo (ivosidenib) is an isocitrate dehydrogenase1- inhibitor, originally approved in 2018.
