• RoundupsRoundups

    FDA Approvals Roundup: Brukinsa

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Brukinsa nabs accelerated approval for previously treated marginal zone lymphoma BeiGene’s Brukinsa (zanubrutinib) has received accelerated approval for expanded use in treating relapsed or refractory  marginal zone lymphoma (MZL) in previously treated adults.   Approval of Brukinsa was based on efficacy findings from two single-arm clin...
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    FDA Approvals Roundup: Trudhesa, Brukinsa, Keytruda

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Trudhesa nasal spray approved for migraine Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate nasal spray) has been approved for acute treatment of migraine with or without aura in adults. Other ergotamine formulations have been previously approved to treat migraine.   The approval was based on findings from the Phase 3, open-label STO...
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    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
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    FDA Approvals Roundup: Skytrofa, Invega Hafyera, Briviact

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Skytrofa approved as weekly therapy for children with growth hormone deficiency Ascendis’s  Skytrofa (lonapegsomatropin-tcgd injection) has been approved as a weekly human growth hormone treatment for children aged 1 year or older who have short stature because of growth hormone deficiency.   The approval was based on efficacy findings from a...
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    FDA Approvals Roundup: Korsuva, Jardiance, Xarelto

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Korsuva okayed for treating moderate-to-severe pruritus in hemodialysis patients Cara Therapeutics’ Korsuva (difelikefalin injection) has been approved for treating moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.   Approval of Korsuva was based on findings from two randomized, multicenter...
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    FDA Approvals Roundup: Jemperli, Welireg, Xywav

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Jemperli cleared for dMMR advanced solid tumors GlaxoSmithKline’s Jemperli (dostarlimab-gxly) has been granted accelerated approval for treating adults  with mismatch repair deficient (dMMR) recurrent or advanced solid tumors whose disease has progressed despite treatment.   The Ventana MMR RxDx Panel was also approved as a companion diagnos...
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    FDA Approvals Roundup: Nexviazyme

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Nexviazyme cleared for late-onset Pompe disease Genzyme’s Nexviazyme (avalglucosidase alfa-ngpt, intravenous infusion) has been approved for treating late-onset Pompe disease in patients aged 1 year or older.   Pompe disease is a rare genetic disorder caused by an enzyme deficiency that drives glycogen accumulation in skeletal and heart m...
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    FDA Approvals Roundup: Semglee, Saphnelo, Uptravi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   FDA Approvals Roundup: Semglee, Saphnelo, Uptravi A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Semglee okayed as first Interchangeable biosimilar insulin product for diabetes Mylan’s Semglee (insulin glargine-yfgn) has been approved as the first interchangeable biosimilar insulin p...
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    July’s Regulatory Focus: Real-world data, real-world evidence

    Feature articles during July focused on real-world data and evidence (RWD and RWE) and their application to approval processes, labeling, clinical use, and marketing of medical products. Articles examined RWD and RWE in the context of patient outcomes and regulatory challenges, especially when conducting noninterventional studies (NIS); regulatory application of RWD-generated external comparators; and from an interregional perspective in the EU, US, and Japan. Also include...
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    FDA Approvals Roundup: Bydureon, Dalvance, Shingrix

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New indications Bydureon use extended for type 2 diabetes in adolescents AstraZeneca’s Bydureon and Bydureon BCise (exenatide extended-release injection) have received expanded indications for improving glycemic control in children aged 10 years or older with type 2 diabetes.   The approval was based on effectiveness and safety findings from a 24-week, d...
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    FDA Approvals Roundup: Rezurock, Fexinidazole, Bylvay

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rezurock cleared for treating chronic graft-versus-host disease Kadmon’s Rezurock (belumosudil) has been approved for treating chronic graft-versus-host disease (GVHD) in adults and children aged 12 years or older after failure of previous systemic therapy.   Approval of the kinase inhibitor was based on efficacy findings from the randomized...
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    FDA Approvals Roundup: Kerendia, Padcev, Darzalex Faspro

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Kerendia cleared for slowing serious kidney, heart complications in type 2 diabetes Bayer’s Kerendia (finerenone tablets) has been approved for reducing the risk of kidney function decline, kidney failure, cardiovascular death, nonfatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with typ...