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
FDA Approves Rezlidhia (olutasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation
Rezlidhia is a potentially market-leading, oral, mutant isocitrate dehydrogenase-1 (mIDH1) inhibitor Phase 2 registrational data supporting the approval showed a 35% CR+CRh rate in mIDH1 R/R AML patie
FDA Approves Rebyota (fecal microbiota, live-jslm) Microbiota-Based Live Biotherapeutic for the Prevention of Recurrence of Clostridioides Difficile Infection
Ferring’s novel first-in-class Rebyota is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatmen
FDA Approves Hemgenix (etranacogene dezaparvovec-drlb) Gene Therapy for Hemophilia B
This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX le
FDA Approves Tzield (teplizumab-mzwv) to Delay the Onset of Stage 3 Type 1 Diabetes
Tzield is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease In a clinical trial, in Stage 2 T1D patients, Tzield delayed the median onset of Stage 3 T1D by 25 months, o
FDA Approves Elahere (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer
Elahere is the First ADC Approved by FDA for Platinum-Resistant Ovarian Cancer Indication Covers Patients with One to Three Prior Systemic Treatment Regimens, Regardless of Prior Avastin® Use VENTANA
FDA Approves Tecvayli (teclistamab-cqyv) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Tecvayli, an off-the-shelf, subcutaneous therapy, is an important new medicine for patients with incurable blood cancer who face limited treatment options HORSHAM, Pa., October 25, 2022 – The Janssen
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