New Warnings for Tofacitinib Issued by FDA
Black box warns of increased risk of blood clots and death.
FDA Approves Hadlima (Adalimumab-bwwd) Biosimilar
TNF blocker biosimilar to Humira (adalimumab, Abbvie).
FDA Approves Ruxience, a Rituxan Biosimilar
CD20-directed antibody indicated for several cancers and other conditions.
First Generic Lyrica Capsules Approved by FDA
Distributed by Invagen, a subsidiary of Cipla Ltd.
FDA Approves Otezla (Apremilast) to Treat Oral Ulcers
Fourth indication for the drug since 2014.
FDA Approves Recarbrio for UTI and Intra-Abdominal Infections
Combination drug indicated for infections caused by susceptible gram-negative bacteria.
New Drug Review: Erdafitinib
First oral drug for advanced or metastatic bladder cancer.
Gadavist (Gadobutrol) Approved as First Cardiac MRI Contrast Agent
Fourth approval for use in assessing myocardial perfusion and late gadolinium enhancement.
Opicapone (Ogentys) for Parkinson’s Disease
COMT inhibitor to be used as an adjunctive treatment to levodopa/carbidopa.
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.
