Global Pediatric Drugs and Vaccines Markets 2016-2024 - Seite 4

6. PRODUCT INTRODUCTIONS/APPROVALS
Actelion Obtains "Epoprostenol Act" Label Extension for Pediatric PAH Patients in Japan
FDA Approves Merck's KEYTRUDA® (pembrolizumab)
Novartis Announces FDAs Acceptance of Company's CAR-T Cell Therapy BLA for Pediatric and Young Adult Patients with r/r B-cell ALL
Boehringer Ingelheim's Tiotropium Respimat® Receives FDA Approval Expansion for Maintenance Treatment of Asthma in Children
Sanofi Pasteur terminates a Vaccine Joint-venture with MSD
ViiV Healthcare Announces the Changed Opinion of CHMP to Lower the Age and Weight Limit for Tivicay® (dolutegravir) in Children and Adolescents Living with HIV in Europe
Shire Announces FDA Approval of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] for Use in Children and Surgical settings
Pfizer Inc. Announces PHASE 3 TRIALs Positive Results of LYRICA® (PREGABALIN) Capsules CV and Oral Solution CV for Treating Pediatric Epilepsy Patients
Pfizer's Prevenar 13® Receives Approval for Use in Infants and Children in China
Simponi® Receives European Commission Approval for Treatment of Polyarticular Juvenile Idiopathic Arthritis
Sanofi Pasteur Launches India's first innovative 6-in-1 vaccine
Shire launches pediatric indication for immunodeficiency treatment HyQvia in Europe
Novo Nordisk's NovoRapid® receives positive opinion from CHMP for extended use in European Union for children as young as one year old
Boehringer Ingelheim Announces the Ability of Tiotropium Respimat® for improving lung function in children aged 6-11
FDA Approves BLINCYTO® (blinatumomab) for Use in Pediatric Patients with Philadelphia Chromosome-Negative Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia
FDA Approves Genentech's Xolair® (omalizumab) for Allergic Asthma in Children
Novartis Receives EU Approval for Revolade® as First-in-class Therapy for Children Aged 1 year and above with Chronic ITP
Pandemic Influenza Vaccine Receives Positive Opinion from CHMP
GSK's Advair® Diskus® Exhibits Primary Endpoint in paediatric LABA' Safety Study
FDA Accepts Amgen's Supplemental Biologics License Application (sBLA) for The Expanded Use Of Enbrel® (Etanercept) To Treat Pediatric Patients with Chronic Severe Plaque Psoriasis
Genentech's supplemental Biologics License Application (sBLA) Receives Acceptance from FDA for reviewing Xolair® (omalizumab)
Shire Partner, Shionogi, Submits New Drug Application in Japan for ADHD treatment for children