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  • RoundupsRoundups

    FDA Approvals Roundup: Remdesivir, Eysuvis, Sklice

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Remdesivir gets the go-ahead for COVID-19 Gilead Sciences’ Veklury (remdesivir) has been approved for the treatment of older children and adults who are hospitalized with COVID-19. [SEE: Remdesivir receives FDA approval for COVID-19 , Regulatory Focus , 22 October 2020]   New indications Eysuvis okayed for short-term treatment of dry e...
  • RoundupsRoundups

    FDA Approvals Roundup: Inmazeb, Wakix, Venclexta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Inmazeb approved as first treatment for Ebola virus Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn combination) has been approved as the first treatment for Zaire ebolavirus (Ebola virus) infection in adults and children. The therapy received orphan drug and breakthrough therapy designations for treating the infection.   ...
  • RoundupsRoundups

    FDA Approvals Roundup: New formulation for Ultomiris

    New formulation Ultomiris gets new formulation for blood-related disorders  Alexion’s Ultomiris (ravulizumab-cwvz injection) has been  approved  as a 100 mg/mL formulation for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) for adults and children aged one month or older.  The  new  formulation of the complement inhibitor will cut annual infusion time by about 60%, or six hours, compared with the 10 m...
  • RoundupsRoundups

    FDA Approvals Roundup: Alkindi, Haegarda, Kalydeco

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Alkindi approved as replacement therapy in children with adrenocortical insufficiency Eton Pharmaceuticals’ Alkindi Sprinkle (hydrocortisone oral granules) has been approved as a replacement therapy for adrenocortical insufficiency (AI) in children younger than 17 years. It is the first FDA-approved granular, lower-dose hydrocortisone formulati...
  • Feature ArticlesFeature Articles

    September’s Regulatory Focus: Countdown to EU MDR and IVDR

    Feature articles during September focused on aspects of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), with articles on compliance and manufacturer obligations, and perspectives examining the current status of the regulations. The issue also included the second part of the cell and gene therapy series, and an article on regulatory tools for generic drug companies.   MDR and IVDR, close up Full implementation of MDR is slated for ne...
  • RoundupsRoundups

    FDA Approvals Roundup: Nucala, Fetroja, Xeljanz

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Nucala gets expanded indication for HES GlaxoSmithKline’s Nucala (mepolizumab injection) has been granted a new indication for the treatment of hypereosinophilic syndrome (HES) in adults and children 12 years and older. The indication is for patients who have had HES for six months or longer, with no other identifiable nonblood-related cause o...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on clinical trials, drug development for EoE

    The US Food and Drug Administration (FDA) has finalized a guidance for industry on development of drugs and therapeutic biologics for treating eosinophilic esophagitis (EoE), a chronic, allergic inflammatory disease of the esophagus, for which there are currently no approved therapies.   The guidance addresses the agency’s thinking on clinical trials and development programs, focusing on trial population and design, efficacy and safety, as well as pediatric considera...
  • RoundupsRoundups

    FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Detectnet okayed for locating neuroendocrine tumors during PET RadioMedix’s Detectnet (copper Cu 64 dotatate injection) has been approved for the detection of somatostatin receptor‒positive neuroendocrine tumors (NETs) in adult patients during imaging with positron emission tomography.   Approval for the radioactive diagnostic agent was sup...
  • RoundupsRoundups

    FDA Approvals Roundup: Gavreto and Trulicity

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approval Gavreto approved for metastatic lung cancer with RET gene fusions Blueprint Medicines’ Gavreto (pralsetinib capsules) has been granted accelerated approval for treating adults with metastatic non‒small cell lung cancer (NSCLC) whose tumors test positive for rearranged during transfection (RET) fusion in an accompanying biomarker assay.   The ass...
  • RoundupsRoundups

    FDA Roundup: Sogroya, Onureg, Winlevi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Sogroya okayed as weekly therapy for adult growth hormone deficiency Novo Nordisk’s Sogroya (somapacitan-beco injection) has been approved as the first once-weekly, human growth hormone (hGH) therapy for adults with growth hormone deficiency.   Until now, the only treatment option for patients with the disorder has been a daily formulation of t...
  • Feature ArticlesFeature Articles

    Regulatory Focus, August issue: Global clinical trials, clinical trial applications

    Feature articles during August focused on global clinical trials and clinical trial applications, with articles on regulatory options for conducting clinical trials in China, a case study on the impact of COVID-19 on submissions to European authorities, and an examination of Canada’s application process and alternate pathway for COVID-19‒related trials. Also included was an article on US Food and Drug Administration (FDA) updates on requirement for EUAs for diagnostics sup...
  • RoundupsRoundups

    FDA Roundup: Kyprolis, Kesimpta, Cystadrops

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Kyprolis in triple combo approved for previously treated multiple myeloma Amgen’s Kyprolis (carfilzomib) has received an expanded indication as a once- or twice-weekly combination with Janssen’s Darzalex (daratumumab) and dexamethasone for relapsed or refractory multiple myeloma in patients previously treated with immunomodulatory drug based (...