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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

FDA Approves Iyuzeh (latanoprost ophthalmic solution) for the Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

Iyuzeh™ (latanoprost ophthalmic solution) 0.005% is the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA) in the United States LEXINGTON

FDA Approves Krazati (adagrasib) for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation

SAN DIEGO, Dec. 12, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a targeted oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated