RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • RoundupsRoundups
    Regulatory NewsRegulatory News

    FDA Approvals Roundup: Sutab, Keytruda, Vimpat

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Sutab approved as tablet-form prep for colonoscopy Sebela’s Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) has been approved as a tablet-form preparation for colonoscopy, providing patients with an alternative to liquid-based preparations.   Colonoscopy is considered the gold standard of screening for colorectal cancer. Ade...
  • RoundupsRoundups

    FDA Approvals Roundup: Totect, Brilinta, Sesquient

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications and formulation Totect nabs expanded indication for doxorubicin-related cardiomyopathy Clinigen’s Totect (dexrazoxane injection) has been granted an expanded indication for reducing the incidence and severity of doxorubicin-induced cardiomyopathy in women with metastatic breast cancer receiving cumulative and maintenance doxorubicin therapy fo...
  • RoundupsRoundups

    FDA Approvals Roundup

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Bronchitol inhalation powder okayed as add-on therapy for cystic fibrosis Chiesi USA’s Bronchitol (mannitol, oral inhalation dry powder) has been approved as an add-on maintenance therapy for improving pulmonary function in patients aged 18 years or older with cystic fibrosis.   Approval of Bronchitol was based on findings from three 26-week...
  • Feature ArticlesFeature Articles

    October’s Regulatory Focus: The regulatory toolbox

    Feature articles during October focused on the regulatory toolbox – the tools for routine regulatory work, from the basics for needed by newcomers to the specialty items needed by seasoned pros  working in the EU and the US. The articles collectively provide accessible, evidence-based, and (mostly) free informational tools, such as health agency guidances and best practices guidelines and advice on effective communication and career options and development.    Setting u...
  • 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...