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  US FDA grants orphan drug designation to Poxel’s PXL770 to treat autosomal-dominant polycystic kidney disease,   October 04, 2022
  Incyte to acquire Medicxi-backed Villaris Therapeutics and its lead asset, auremolimab,   October 04, 2022
  AmplifyBio buys PACT Pharma assets to enhance cell and gene therapy characterization capabilities,   October 04, 2022
  European Commission Decision Reliance Procedure extends by 12 months,   October 03, 2022
  EMA’s safety committee recommends terlipressin-containing medicines to treat hepatorenal syndrome,   October 03, 2022
  Taiho’s Lytgobi gets US FDA approval for previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma,   October 03, 2022
  EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products,   October 01, 2022
  Emmes acquires Clinical Edge; Expands global reach,   October 01, 2022
  InflaRx seeks US FDA emergency use authorization for vilobelimab to treat critically Ill Covid-19 patients,   September 30, 2022
  US FDA accepts for priority review of Pharming’s NDA for leniolisib to treat the rare primary immunodeficiency activated APDS,   September 30, 2022
  Pfizer, BioNTech complete submission to EMA for Omicron BA.4/BA.5-adapted bivalent vaccine booster in children 5 through 11 years of age,   September 30, 2022
  Chugai files NDA in Japan for fixed-dose subcutaneous combination of pertuzumab & trastuzumab for HER2-positive breast and colorectal cancer,   September 30, 2022
  US FDA approves Dupixent to treat adults patients with prurigo nodularis,   September 30, 2022
  Pall Corporation launches 3 new Allegro Connect Systems,   September 29, 2022
  Koselugo approved in Japan for paediatric patients with plexiform neurofibromas in neurofibromatosis type 1,   September 28, 2022
  AstraZeneca’s Tezspire receives Japanese approval to treat severe asthma with no phenotype or biomarker limitations,   September 28, 2022
  Merck’s Keytruda gets four new approvals in Japan, including in high-risk early-stage triple-negative breast cancer,   September 28, 2022
  BioIVT acquires Southeastern Europe-based Fidelis Research,   September 27, 2022
  WuXi STA opens first high potency oral drug product manufacturing facility at its Wuxi city campus,   September 27, 2022
  Daiichi Sankyo gets Japan MHLW approval for Ezharmia as first dual EZH1 & EZH2 inhibitor therapy for adult t-cell leukaemia/lymphoma,   September 27, 2022

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