• RoundupsRoundups

    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, ...
  • Regulatory NewsRegulatory News

    EMA releases final guideline on antibacterial drug development

    The European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that is globally aligned with guidance from other regulators.   EMA said the document addresses a “pressing need for new antibacterial agents suitable for treating infections in patients with few remaining therapeutic options.”   The agency announced that antimicrobial resistance poses a “global threat” and is responsible for an estimated 33,000 deaths per yea...
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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 ...
  • Feature ArticlesFeature Articles

    In-house regulatory database development: Solution for a competitive oncology landscape

    The unprecedented number of new investigational agents in clinical development in the competitive oncology space presents a significant challenge for regulatory intelligence professionals. Strategic decisions are complicated by the overwhelming amount of regulatory information scattered across numerous repositories. The development of an in-house database may facilitate success for businesses in the prevailing information-centric world. Effective implementation of an in-ho...
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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...
  • RoundupsRoundups

    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 ...
  • Regulatory NewsRegulatory News

    Generic drug approvals continued to fall in 2021

    The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in recent years.   In calendar year 2020 , FDA approved or tentatively approved 948 ANDAs for generic drugs, which was down from 1,014 in 2019 . The latest figures are part of the FDA’s Office of Generic Drugs (OGD) 2021 Annual Report .   But the agency approved 93 “fi...