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  • RoundupsRoundups

    FDA Approvals Roundup: Cytalux, Lyvispah, Caldolor

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Cytalux okayed for aiding identification of ovarian cancer lesions during surgery On Target Laboratories’ Cytalux ( pafolacianine ) has been approved as a diagnostic agent in assisting surgeons identify cancerous lesions in women with ovarian cancer.   The intravenous imaging drug is administered before surgery to improve detection of addi...
  • RoundupsRoundups

    FDA Approvals Roundup: Voxzogo, Fyarro, Livtencity

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).    New approvals   Voxzogo cleared  as growth-improvement therapy for children with dwarfism   BioMarin’s  Voxzogo (vosoritide injection) has been  approved  for improv ing growth in children aged 5 years or older with achondroplasia and open epiphyses, or growth plates.    Achondroplasia is the most common form of dwarfism. Children with open  epiph...
  • RoundupsRoundups

    FDA Approvals Roundup: Besremi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Besremi okayed for rare blood disease PharmaEssentia’s Besremi (ropeginterferon alfa-2b-njft injection) has been approved for treating adults with polycythemia vera, a blood disease caused by a JAK2V617F mutation that results in overproduction of red blood cells (RBCs).   The monopegylated, long-acting interferon alfa-2b reduces excess RBCs...
  • RoundupsRoundups

    FDA Approvals Roundup: Eprontia, Dyanavel

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Eprontia okayed as liquid form for treating epilepsy and migraine Azurity’s Eprontia (topiramate) oral solution has been approved for treating seizures and migraines. The approval covers use of the anticonvulsant as a monotherapy and adjunctive therapy for seizures in patients aged 2 years or older and as a preventive treatment for migraine in...
  • Feature ArticlesFeature Articles

    October’s Regulatory Focus: Linguistic review, advanced therapies in Asia-Pacific, and more

    Feature articles during October included an in-depth look at the linguistic review process in Europe and  reviews of the regulatory pathways for herbal medicinal products, medical devices, and supplements in the EU and for advanced therapies in the Asian-Pacific region. Also included was an article on the challenges of data integrity remediation in cGMP facilities.   Linguistic review and herbal product regulation The linguistic review process for centrally authori...
  • RoundupsRoundups

    FDA Approvals Roundup: Scemblix, Vuity, Cortrophin Gel

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Scemblix okayed for chronic myeloid leukemia with Philadelphia mutation Novartis’s Scemblix (asciminib) has been granted accelerated approval as a therapy for adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML in CP) who have received previous treatment with two or more tyrosine kinase inhibitors (...
  • RoundupsRoundups

    Approvals Roundup: Xipere, Seglentis, Dupixent

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Xipere okayed for uveitis-associated macular edema Clearside’s  Xipere (triamcinolone acetonide injectable suspension) has been approved for use in the  suprachoroidal space of the eye to treat macular edema associated with non-infectious uveitis.   The approval of the corticosteroid was based on findings from the Phase 3 randomized, mul...
  • RoundupsRoundups

    FDA Approvals Roundup: Tyrvaya, Zimhi, Biktarvy

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tyrvaya nasal spray okayed for dry eye disease Oyster Point’s Tyrvaya (varenicline solution nasal spray) has been approved for treating dry eye disease.   Approval for Tyrvaya, a highly selective cholinergic agonist, was based on efficacy findings from the randomized, multicenter, double-masked, vehicle-controlled ONSET-1 , ONSET-2 , and...
  • RoundupsRoundups

    FDA Approvals Roundup: Tavneos, Verzenio, Dextenza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tavneos okayed for ANCA-associated vasculitis ChemoCentryx’s Tavneos (avacopan) has been approved as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, also known as ANCA-associated vasculitis, in combination with standard therapy.   ANCA-associated vasculitis is a group of thr...
  • Feature ArticlesFeature Articles

    September’s Regulatory Focus: Diversity in regulatory affairs, clinical trials, and more

    Feature articles during September focused on diversity in regulatory affairs, challenges in conducting medical device clinical trials in Europe, clinical trial regulation and laws in China, and risk management in working with third-party distributors.   Equity in action, diversity, and resilience In Fall 2020, representatives from Pfizer Global Regulatory Affairs (GRA) and the Howard University College of Pharmacy (HUCOP) initiated discussions about creating a care...
  • RoundupsRoundups

    FDA Approvals Roundup: Livmarli and Tecartus

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Livmarli approved for cholestatic pruritus in children with Alagille syndrome Mirum’s Livmarli (maralixibat oral solution) has been approved for treating cholestatic pruritus in patients aged 1 year or older who have Alagille syndrome (ALGS).   ALGS is a rare genetic disorder caused by abnormalities in bile ducts that can lead to progressive ...
  • RF Quarterly

    RF Quarterly, October 2021: Quality and compliance

    Welcome to the fall issue of RF Quarterly in which international experts from the US, EU, and Saudi Arabia examine quality and compliance and their governing regulations, with specific focus on data integrity, quality system design and management, current good manufacturing practice (cGMP), and postmarketing activities in relation to medical devices, pharmaceuticals, and biologics.   Pragmatism, integrity, and QMS Data reliability in all formats and parts of an o...