雅虎財經1 個月
FDA Green Lights Pfizer's Gene Therapy For Rare Bleeding Disorder Hemophilia
Friday, the FDA approved Pfizer Inc’s (NYSE:PFE) Beqvez (fidanacogene elaparvovec-dzkt) for moderate to severe hemophilia B in adult patients who currently use factor IX (FIX) prophylaxis therapy or ...
Yahoo Finance24 天
FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY T-CELL ENGAGER THERAPY FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER
Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median ...
BioSpace25 天
FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY T-CELL ENGAGER THERAPY FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER
THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of ...
rarediseaseadvisor26 天
FDA Approves Companion Diagnostic for Hemophilia B Gene Therapy
Results from the nAbCyte test will indicate whether an individual can proceed with gene therapy. The US Food and Drug Administration (FDA) has approved the nAbCyte ™ Anti-AAVRh74var HB-FE assay as a ...
CBS News2 天
FDA approves first RSV vaccine for at-risk adults in their 50s
The Food and Drug Administration has approved giving GSK's vaccine for respiratory syncytial virus down to age 50 years old, to those who are at higher risk of severe RSV, the company said Friday ...
Benzinga.com3 天
FDA Approves Geron's First Commercial Drug, Competes With Bristol Myers Squibb's Blood Cancer Drug
Geron's CEO said the company anticipates a peak market potential of $1.2 billion in the US and some key EU countries by 2030. In March, by a 12-to-2 margin, the FDA adcomm panel voted in favor of ...
雅虎財經1 個月
Second Death - Pfizer Reports Young Boy's Death After One Year Of Gene Therapy Treatment In Muscle Wasting Disorder Trial
A young patient died due to cardiac arrest after receiving Pfizer Inc’s (NYSE:PFE) experimental gene therapy in a mid-stage trial for Duchenne muscular dystrophy (DMD), the company told in a letter to ...
Neurology Advisor4 天
FDA Approves First Liquid, Nonstimulant ADHD Treatment
The centrally acting alpha2-adrenergic agonist is approved for patients ≥6 years. HealthDay News — The US Food and Drug Administration has approved once-daily Onyda XR (clonidine hydrochloride ...
Benefits Pro7 天
Gene therapy and employee benefits: from science fiction to medical reality
Gene therapy is a new medical breakthrough which has, in reality, been several decades in the making. The concept was first suggested 50 years ago as a possibility for targeted treatments, but it ...
PipelineReview.com24 天
FDA approves Imdelltra™ (tarlatamab-dlle), the first and only T-cell engager therapy for the treatment of extensive-stage small cell lung cancer
IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study THOUSAND OAKS, CA, USA I May 16 ...
NBC New York3 天
FDA approves GSK's RSV vaccine for high-risk adults ages 50 to 59, expanding shot's reach
The Food and Drug Administration expanded the approval of GSK's respiratory syncytial virus vaccine to adults ages 50 to 59 who are at increased risk of getting severely sick from the virus.