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    FDA Approvals Roundup: Xalkori, Darzalex Faspro, Enhertu

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Xalkori gets expanded indication for advanced anaplastic large-cell lymphoma in young patients Pfizer’s Xalkori (crizotinib) has been approved for treating relapsed or refractory systemic, ALK-positive anaplastic large cell lymphoma (ALCL) in patients aged 1 to 21 years. The drug’s safety and efficacy has not been established in older adults w...
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    FDA’s AI/ML action plan includes ‘tailored’ regulatory framework for SaMD

    The US Food and Drug Administration has released a five-part action plan for its oversight of artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) based on feedback from developers and manufacturers on an April 2019 discussion paper.   Top of the action-plan list is the agency’s intention to develop a “tailored” regulatory framework for the medical software by issuing draft guidance on the Predetermined Change Control Plan outl...
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    FDA Approvals Roundup: Gemtesa

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Gemtesa gets the green light for treating adults with overactive bladder Sumitovant Biopharma’s Gemtesa (vibegron tablet) has been approved as a therapy for adults with overactive bladder (OAB).   The approval was based on efficacy and safety findings from the 12-week double-blind, placebo-controlled phase 3 EMPOWUR study and the double-b...
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    FDA Approvals Roundup: Ebanga, Margenza, Orgovyx

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Ebanga wins approval for treating Zaire Ebolavirus in adults and children Ridgeback Biotherapeutics’ Ebanga (Ansuvimab-zykl) has been approved for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children, making it the second approval for the virus since  Regeneron’s antibody cocktail, Inmazeb , was greenlighted in October. ...
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    FDA Approvals Roundup: Klisyri and Ocrevus

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Klisyri approved as topical therapy for actinic keratosis Almirall’s Klisyri (tirbanibulin ointment) has been approved as a topical, self-administered treatment for actinic keratosis (AK) of the face or scalp.   The novel, first-in-class microtubule inhibitor is notable for its short treatment protocol of a once-daily application for 5 days...
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    Q4 Regulatory Focus Article Series: Regulatory Intelligence

    Q4 Regulatory Focus Article Series: Regulatory Intelligence   RAPS is pleased to bring you another edition of its Regulatory Focus Article Series, comprised of timely and relevant technical articles, case studies, interviews, and research reports. These topic-focused collections are intended to benefit RAPS members responsible for healthcare-related products. Articles are developed by global subject-matter experts representing a range of regulatory responsibiliti...
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    FDA Approvals Roundup: Orladeyo, Saxenda

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Orladeyo approved as prophylactic for hereditary angioedema BioCryst’s Orladeyo (berotralstat) has been approved for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and children aged 12 years or older, making it the first orally administered, nonsteroidal option for preventing these attacks.   HAE is a rare genetic con...
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    FDA Approvals Roundup: Imcivree, Danyelza, Ga 68 PSMA-11

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Imcivree okayed as first therapy for managing obesity in some rare genetic conditions Rhythm Pharmaceutical’s Imcivree (setmelanotide) has been approved for chronic weight management in patients aged 6 years or older with obesity related to three rare genetic conditions.   Imcivree is the first treatment approved for pro-opiomelanocortin...
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    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...
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    FDA Approvals Roundup: Zokinvy, Oxlumo, Xofluza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Zokinvy okayed as first therapy for rare premature aging diseases Eiger BioPharmaceuticals’ Zokinvy (lonafarnib capsules) has been approved for reducing the risk of death from Hutchinson-Gilford progeria syndrome and treating certain processing-deficient progeroid laminopathies in patients aged 1 year or older. The rare genetic diseases cause pre...
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    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...
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    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...