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    FDA Approvals Roundup: Evrysdi, Kymriah, Tibsovo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Evrysdi gets label extension for use in babies with spinal muscular atrophy Genentech’s Evrysdi ( risdiplam; powder for oral solution ) has been granted a new indication to include babies younger than 2 months with spinal muscular atrophy (SMA).   The approval is based on interim findings from the RAINBOWFISH study in newborns demonstrat...
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    FDA Approvals Roundup: Vtama, Dupixent, Vidaza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Vtama approved as topical, steroid-free treatment for plaque psoriasis in adults Dermavant’s VTAMA ( tapinarof; cream, 1% ) has been approved as a steroid-free, topical treatment for adults with mild-severe plaque psoriasis.   Approval of the aryl hydrocarbon receptor agonist was based on findings from the Phase 3, multicenter, double-blind, ...
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    FDA Approvals Roundup: Mounjaro and Radicava ORS

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Mounjaro okayed as dual-targeted therapy for type 2 diabetes Eli Lilly’s Mounjaro ( tirzepatide; injection ) has been approved for improving blood sugar control in adults with type 2 diabetes, in combination with diet and exercise.   Mounjaro is a dual agonist for the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polyp...
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    FDA Approvals Roundup: Olumiant, Enhertu

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Olumiant use extended for hospitalized COVID-19 patients needing oxygen support Eli Lilly’s Olumiant (baricitinib tablets ) has been granted a new indication for treating COVID-19 in hospitalized adults who require varying degrees of ventilation/oxygen support.   Olumiant has been available to treat COVID-19 in the US under emergency use ...
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    FDA Approvals Roundup: Vijoice, Hyftor, Yescarta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Vijoice okayed for PIK3CA-related overgrowth spectrum Novartis’s Vijoice ( alpelisib ) has been granted accelerated approval for treating severe manifestations of PIK3CA-related overgrowth spectrum (PROS) in adults and children aged 2 years or older who require systemic therapy.   This indication for Vijoice, a kinase inhibitor, was approved...
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    FDA Approvals Roundup: Pluvicto, Cabenuva, Fintepla

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Pluvicto approved for metastatic, castration-resistant prostate cancer Advanced Accelerator Applications’ Pluvicto ( lutetium [Lu 177] vipivotide tetraxetan; injection ) is approved as a radioligand therapy for metastatic castration-resistant prostate cancer in men who are positive for prostate-specific membrane antigen and have been treated wi...
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    FDA Approvals Roundup: Ztalmy, Opdualag, Keytruda

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Ztalmy gets go-ahead for rare form of genetic epilepsy in children, adults Marinus Pharmaceuticals’ Ztalmy ( ganaxolone; oral suspension ) has been approved for treating seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD), a rare form of genetic epilepsy, in patients aged 2 years or older.   Approval of Ztal...
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    FDA Approvals Roundup: Adlarity and Lynparza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Adlarity transdermal patch okayed for dementia in patients with Alzheimer’s disease Corium’s Adlarity ( donepezil; transdermal system ) has been approved for mild, moderate, or severe dementia in patients with Alzheimer's disease. The drug was approved via the 505(b)(2) pathway that allows drugs to be approved based in part on data from stud...
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    FDA Approvals Roundup: Pyrukynd and Solosec

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Pyrukynd cleared for hemolytic anemia in adults with rare genetic disorder Agios Pharmaceuticals’ Pyrukynd ( mitapivat; tablets ) has been approved for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency, a rare genetic disorder that causes the destruction of red blood cells, leading to anemia.   The approval was based ...
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    FDA Approvals Roundup: Vabysmo, Cabenuva, Vonvendi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Vabysmo approved for treating two types of macular disease Genentech’s Vabysmo ( faricimab-svoa; injection ) has been approved for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME) in adults. The bispecific antibody targets and inhibits the disease pathways in the respective conditions.   Approval of Vabysmo...
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    FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Ryaltris okayed for seasonal allergic rhinitis Glenmark’s Ryaltris ( olopatadine and mometasone furoate; nasal spray ) has been approved for seasonal allergic rhinitis in adults and pediatric patients aged 12 years or older.   The approval of Ryaltris was based on findings from two multicenter, randomized, double-blind, placebo-and active-co...
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    FDA Approvals Roundup: Quviviq, Recorlev, Rexulti

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Quviviq nabs go-ahead for insomnia in adults Idorsia’s Quviviq ( daridorexant; tablets ) has been approved for treating adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance, pending controlled substance scheduling.   The approval was based on efficacy findings in two studies ( Study 1 and Study 2 )...