FDA Expands Use of COVID-19 Vaccine Booster Dose in Eligible Populations
The US Food and Drug Administration has granted approval for administration of COVID-19 vaccine booster dosage, upgrading the emergency use
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Regulatory
Genentech’s Investigational Antibody Wins BTD for Alzheimer’s Treatment
Genentech’s investigational antibody for the treatment of early-stage Alzheimer’s disease, Gantenerumab, has been granted Breakthrough Therapy Designation by the U.S.
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Tezepelumab gets ODD in the US for Eosinophilic Esophagitis
Tezepelumab, developed by AstraZeneca in collaboration with Amgen, has been granted Orphan Drug Designation (ODD) in the US FDA for
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WHO Endorses GlaxoSmithKline’s Breakthrough Malaria Vaccine
The World Health Organization on Wednesday endorsed the groundbreaking GlaxoSmithKline Malaria vaccine for children at risk reinvigorating the fight against
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FDA OK’s Tecartus® CAR T-cell Therapy for B-cell Acute Lymphoblastic Leukemia
Kite Pharma, a Gilead Company, announced on Friday that the U.S. FDA has granted approval for CAR T-cell therapy Tecartus®
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Japan’s MHLW Approves Pfizer’s CIBINQO® for Atopic Dermatitis
Pfizer has reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) authorized CIBINQO® (abrocitinib), a novel therapy for
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Pfizer and BioNTech Submit Initial Trial Data from COVID-19 Vaccine Phase 2/3 Study in Children to the FDA
Pfizer and BioNTech reported that data from their COVID-19 vaccine Phase 2/3 study in children aged 5 to 12 years
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FDA Approves Antibody-drug Conjugate TIVDAK™ for Recurrent or Metastatic Cervical Cancer
Genmab A/S and Seagen Inc. revealed that the first and only approved antibody-drug conjugate (ADC) known as TIVDAK™ (tisotumab vedotin-tftv),
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Amgen’s KRAS G12C Inhibitor Lumykras™ Receives MHRA Authorisation
Amgen’s first-in-class KRAS G12C inhibitor LumykrasTM (sotorasib) has been granted Conditional Marketing Authorisation by the Medicines and Healthcare products Regulatory
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International Respiratory Coalition Launches to Improve Post-Pandemic Respiratory Care
The European Respiratory Society (ERS), the Global Allergy and Airways Patient Platform (GAAPP), AstraZeneca, Amgen and leading respiratory clinicians announced
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