NDA News-CliniExpert

FDA Approves Jesduvroq (daprodustat) for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis

February 01, 2023 -- Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chroni

FDA Approves Jaypirca (pirtobrutinib) for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma

Jaypirca is the first BTK inhibitor of any kind specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor In the BRUIN Phase 1/2 trial, covalent BTK

FDA Approves Orserdu (elacestrant) for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer

ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been diffic

FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes

MARLBOROUGH, Mass.--(BUSINESS WIRE) January 23, 2023 --TheracosBio today announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotra

FDA Approves Rykindo (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia and Bipolar 1 Disorder

PRINCETON, N.J., Jan. 15, 2023 /PRNewswire/ -- Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications, toda

FDA Approves Airsupra (albuterol/budesonide) Metered-Dose Inhaler to Reduce the Risk of Asthma Exacerbations

January 11, 2023 -- Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exa

FDA Approves Leqembi (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease

Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with Leqembi™ Treatment with Leqembi should be initiated in patients with mild co

FDA Approves Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis

NEW YORK, Dec. 28, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the U.S. Food and Drug Administration (FDA) has approved Briumvi™ (ublituximab-xiiy), for the treatment

FDA Approves Sunlenca (lenacapavir) Twice-Yearly Treatment for People Living With Multi-Drug Resistant HIV

Sunlenca is the First and Only Approved Capsid Inhibitor-Based HIV Treatment Option New Drug Application Approval Based on High Rates of Sustained Virologic Suppression in the CAPELLA Trial FOSTER CIT

FDA Approves Lunsumio (mosunetuzumab-axgb) a First-in-Class Bispecific Antibody to Treat People With Relapsed or Refractory Follicular Lymphoma

With Lunsumio, people with heavily pretreated follicular lymphoma (FL) may experience remission with a chemotherapy-free, fixed-duration treatment that can be accessed in an outpatient setting Results

FDA Approves Adstiladrin (nadofaragene firadenovec-vncg) for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Ferring’s novel adenovirus vector-based gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) is the first gene therapy approved for bladder cancer Efficacy and safety of Adstiladrin supported by

FDA Approves Idacio (adalimumab-aacf), a Biosimilar to Humira

Idacio® is a citrate-free formulation of adalimumab Idacio® expands Fresenius Kabi’s U.S. biosimilars portfolio focused on immunology and oncology Idacio® is Fresenius Kabi’s second approved U.S. bios