Age Group – Page 3

FDA Expands Approval of GSK’s RSV Vaccine to Include At-Risk Adults Aged 50-59

11 months ago talkbio0Tagged Adult, Approved, Arexvy, At-Risk, Respiratory syncytial virus, Respiratory Syncytial Virus Vaccines, SmithKline Beecham, United States Food and Drug Administration

RSV vaccine, GSK, FDA approval, at-risk adults, respiratory syncytial virus, Arexvy

Duchenne Muscular Dystrophy: Potential Inclusion in Newborn Screening Programs

12 months ago talkbio0Tagged Decision Making, Diagnosis, Infant, Newborn, medical experts, Muscular Dystrophy, Duchenne

Duchenne muscular dystrophy, newborn screening, medical experts, decision-making, early diagnosis, treatment options.

Pioneering Gene Therapy Restores Hearing in Children with Otoferlin-Linked Deafness

12 months ago talkbio0Tagged Child, Clinical Trials, gene therapy, Hearing, hearing restoration, Mutation

Gene therapy, otoferlin-related deafness, hearing restoration, children, genetic mutation, clinical trial, auditory function.

FDA Fast-Tracks Day One’s Innovative Therapy for Pediatric Brain Tumors

1 year ago talkbio0Tagged Accelerated, Approved, Brain Neoplasms, Cancer Therapeutic Procedure, cellular targeting, Child, Day One, Glioma, Pediatric brand name, United States Food and Drug Administration

FDA, accelerated approval, Day One, targeted treatment, pediatric brain tumors, glioma, children, cancer treatment, innovative therapy.

AstraZeneca’s FASENRA Gains FDA Approval for Add-On Maintenance Treatment of Severe Asthma in Children Aged 6-11

1 year ago talkbio0Tagged Age, Approved, AstraZeneca, benralizumab, Child, expansion, Fasenra, Pediatric Label, Severe asthma, United States Food and Drug Administration

AstraZeneca, FASENRA, Benralizumab, Severe Asthma, Pediatric Label Expansion, FDA Approval, Children Aged 6-11

FDA Grants Emergency Authorization for Invivyd’s Pemgarda Antibody Prophylactic Against COVID-19 in Immunocompromised Individuals

1 year ago talkbio0Tagged Adolescent (age group), Adults/, Approved, Condoms, Male, COVID19 (disease), Emergency Use Authorization, Half-Life Extended Monoclonal Antibody, immune compromise, Immunocompromised Host, Invivyd, Moderate (severity modifier), Pemgarda, pemivibart, Pre-Exposure Prophylaxis, Prophylactic treatment, Severe (severity modifier), United States Food and Drug Administration, VYD222

Invivyd, Pemgarda (pemivibart; formerly VYD222), Half-Life Extended Monoclonal Antibody, COVID-19 Prophylactic, Immunocompromised Patients, Emergency Use Authorization (EUA), FDA Approval, Moderate to Severe Immune Compromise, Pre-exposure Prophylaxis (Prevention) of COVID-19 in Adults/ Adolescents

FDA Grants First Approval for Orchard Therapeutics’ Gene Therapy Lenmeldy in Treating Rare Pediatric Neuron Disease

1 year ago talkbio0Tagged Approved, Autologous Gene Therapy, Infantile/, Juvenile, Lenmeldy, Leukodystrophy, Metachromatic, Orchard, Pre-Symptomatic Late, Rare Pediatric Disease, United States Food and Drug Administration

Orchard Therapeutics, Lenmeldy, FDA Approval, Metachromatic Leukodystrophy (MLD), Rare Pediatric Disease, Autologous Gene Therapy, Pre-Symptomatic Late Infantile/ Early Juvenile Patients

FDA Grants Accelerated Approval to Madrigal’s Rezdiffra for MASH Treatment

1 year ago talkbio0Tagged Accelerated clearance, Adult, Antibody-Drug, Approved, Madrigal Pharmaceuticals, metabolic dysfunction-associated steatohepatitis, moderate-to-advanced liver fibrosis, Non-cirrhotic, resmetirom, Rezdiffra, United States Food and Drug Administration

FDA approval, Madrigal Pharmaceuticals, Rezdiffra (resmetirom), Metabolic dysfunction-associated steatohepatitis (MASH), Accelerated clearance, Adult patients with non-cirrhotic MASH and moderate-to-advanced liver fibrosis