FDA Approves First Drug Under Project Orbis
Combination therapy for advance endometrial carcinoma.
Tenapanor Approved for Adults with IBS-C
NHE3 inhibitor administered as 50 mg oral tablets.
FDA Grants Tepotinib Breakthrough Therapy Designation
Investigational oral MET kinase inhibitor from Merck.
FDA Approves New Generic for Rare HT-1 Disorder
Oral supplements for metabolic disorder.
Decitabine and Fosaprepitant Generics Approved by FDA
First generic specialty injections approved for Novadoz Pharmaceuticals.
New Drug Review: Vraylar for Bipolar I Disorder
Cariprazine demonstrated greater improvement on the MADRS.
FDA Approves Lefamulin for Community-Acquired Bacterial Pneumonia
New pleuromutilin antibiotic IV and oral tablets.
FDA Approves Upadacitinib for Severely Active RA
Humira successor indicated for adults with inadequate response or intolerance to methotrexate.
FDA Approves Fedratinib (Inrebic) for Myelofibrosis
First new drug approval for the condition in nearly a decade.
FDA Approves Turalio (Pexidartinib) for TGCT
Kinase inhibitor oral capsules.
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