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One in Two

The University of Manchester

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With one in two of us receiving a cancer diagnosis at some point during our lives, it has never been more important to improve the outcomes for people affected by cancer. This cancer research podcast is brought to you by The University of Manchester in partnership with the Manchester Cancer Research Centre (MCRC). In each episode, our cancer researchers discuss the innovations, discoveries and projects that are changing the landscape of early detection.
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New FDA Approvals

Emma Hitt Nichols, PhD

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The New FDA Approvals podcast is a weekly podcast that aims to help clinicians, medical writers, and pharmaceutical industry executives stay up to date on the latest FDA approvals. Join Dr. Emma Hitt Nichols each Monday morning for an update on the previous week’s FDA activities.
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Use AI to Speed up Your Work Flow Ethically and Securely. There are lots of courses on AI out there, but this one is specific only to medical writing and editing. Access the AIMWE course waitlist. https://www.learnamastyle.com/waitlist/ Leqselvi for Alopecia Areata: The FDA has approved deuruxolitinib (Leqselvi) as a first-line treatment for adults…
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Visit learnAMAstyle.com to uplevel your writing and editing skills with free downloads on medical writing and editing. The FDA has approved vonoprazan (Voquenza) for treating non-erosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is an oral potassium-competitive acid blocker (PCAB) already approved for erosive esophagitis and Heli…
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Visit learnAMAstyle.com for free downloads in writing in medicine and the life sciences.  The FDA has approved blinatumomab (Blincyto) for treating adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase. This bispecific T-c…
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Visit learnamastyle.com for free downloads and free courses related to writing in medicine and science. - The FDA has approved donanemab (Kisunla) for early symptomatic Alzheimer's disease, making it the third drug in a new class aimed at slowing cognitive decline in early-stage patients. Eli Lilly will make the drug available within weeks followin…
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Do you work for a CME company that needs urgent medical writing assistance? We can help. Visit nascentmc.com - The FDA has approved ensifentrine (Ohtuvayre) as an inhaled maintenance therapy for adults with COPD. Ohtuvayre is the first new mechanism of action for COPD treatment in over two decades, offering anti-inflammatory and bronchodilatory eff…
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Visit nascentmc.com for the full writup of this episode and medical writing assistance. Visit learnamastyle.com for free downloads directed towards medical writing and editing. • The FDA has approved the 21-valent pneumococcal conjugate vaccine, CAPVAXIVE™ (Merck), for the prevention of invasive disease and pneumonia in adults aged 18 years and old…
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Check out Nascentmc.com for medical writing assistance. visit learnAMAstyle.com for free downloads on medical writing and editing Adbry for Atopic Dermatitis The FDA has approved tralokinumab-ldrm (Adbry) as a 300 mg single-dose autoinjector for moderate-to-severe atopic dermatitis (AD) in adults, offering a more convenient delivery method. Adbry, …
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Nascentmc.com for medical writing assistance for your company. Visit learnAMAstyle.com for free downloads on medical writing and editing Klisyri for Actinic Keratosis: The FDA has approved tirbanibulin (Klisyri) for treating actinic keratosis (AK) on larger areas of the face or scalp, up to 100 cm². Previously approved for areas up to 25 cm² in Dec…
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Go here for complete show notes. Visit learnAMAstyle.com for free downloads on medical writing and editing Nascentmc.com for medical writing assistance for your company. mRESVIA for Lower Respiratory Tract Disease The FDA approved mRNA-1345 (mRESVIA) for preventing RSV-caused lower respiratory tract disease in adults 60 and older, based on Phase 3 …
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For medical writing assistance, please visit nascentmc.com learnAMAstyle.com for the AI in Medical Writing and Editing: Blueprint for Success in a Changing World course to assist with implementing AI in medical writing. • Imdelltra for EC-SCLC: The FDA granted accelerated approval for tarlatamab-dlle (Imdelltra) for adults with extensive-stage smal…
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Visit NascentMC.com for medical writing assistance. Visit learnAMAstyle.com for information on AI in Medical Writing and Editing - **mRNA Anti-EBV Cancer Vaccine**: The novel mRNA therapeutic cancer vaccine WGc-043 has been approved for clinical trials by the FDA, targeting Epstein-Barr virus (EBV) related cancers such as nasopharyngeal carcinoma a…
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Please visit Nascentmc.com for medical writing assistance for your company. Visit learnAMAstyle.com for free downloads on medical writing and editing Ingrezza for Huntington’s: The FDA has approved valbenazine (INGREZZA® SPRINKLE) capsules for adults with tardive dyskinesia and chorea associated with Huntington's disease. This new oral granules for…
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VIsit Nascentmc.com for medical writing assistance. Visit learnamastyle.com for freebies on medical writing and editing and ChatGPT. - Fasenra Pediatric Asthma Expansion: No details provided for this update. - Beqvez for Hemophilia B: FDA approved gene therapy, Beqvez, for adults with moderate to severe hemophilia B, which enables the production of…
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Visit nascentmc.com/podcast for full show notes. - The FDA has expanded the approval of benralizumab (Fasenra) to include children aged 6 to 11 with severe eosinophilic asthma, building on its previous approval for patients aged 12 and older. Benralizumab is a monoclonal antibody that targets and reduces eosinophilic inflammation, crucial in the se…
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In the latest episode of One in Two: A Manchester Cancer Research Podcast, we speak to Professor Matt Evison, Professor of Thoracic oncology, and never-smoker ALK+ lung cancer patient, Sally Hayton about: · Never-smoker lung cancer symptoms, demographics, and occurrence · Sally’s experience of receiving her lung cancer diagnosis and the barriers sh…
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· Nascentmc.com for medical writing assistance for your company.Visit nascentmc.com/podcast for full show notes Cilta-cel for Myeloma: The FDA approved ciltacabtagene autoleucel (Carvykti; cilta-cel) for adults with relapsed or refractory multiple myeloma who have tried at least one prior therapy including a proteasome inhibitor and an immunomodula…
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Visit nascentmc.com/podcast for full show notes Winrevair for PAH: Sotatercept-csrk (Winrevair) is FDA-approved for treating adults with pulmonary arterial hypertension (PAH), enhancing exercise capacity, improving WHO functional class, and reducing clinical worsening events. It's the first FDA-approved activin signaling inhibitor for PAH, addressi…
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Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes Visit learnAMAstyle.com for free downloads regarding editing and the AMA Manual of Style tip sheet. Nexletol and Nexlizet for LDL Lowering and CV Risk: The FDA approved bempedoic acid (Nexletol) and its combination with ezetimibe (Nexlizet…
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Please visit nascentmc.com/podcast for all the details. Go to learnAMAstyle.com for lots of freebies on AMA Style and the use of AI in medical writing and editing Here is information on the latest US FDA approvals, the week of March 11 – March 15, 2024 Liso-cel for CLL/SLL - The FDA approved lisocabtagene maraleucel (liso-cel; Breyanzi) for adult p…
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Here is information on the latest US FDA approvals, the week of March 4 – March 8, 2024 · ChatGPT4 in medical writing and editing—visit learnAMAstyle.com · Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes - **OTC Glucose Monitor**: The FDA has approved the Dexcom Stelo Glucose Biosensor …
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In this episode, we speak to Professor David Wedge, Professor of Cancer Genomics and Data Science, about breast cancer in Black African women, focussing on: · Cancer genomics and what we understand ethnicity to be in the context of genomic research · David’s work within the International Cancer Genome Consortium · The increase in aggressiveness of …
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Visit nascentmc.com/podcast for full show notes Visit learnamastyle.com for the free course on ChatGPT4 for medical writers and editors. - The FDA has approved amivantamab (Rybrevant) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSC…
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· ChatGPT4 in medical writing and editing FREE COURSE at learnAMAstyle.com · Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes Enmetazobactam for cUTI: The FDA approved enmetazobactam (Exblifep) for complicated urinary tract infections (cUTIs) in adults, offering a new weapon against anti…
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` Free course on ChatGPT4 in medical writing and editing at learnAMAstyle.com · Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes Lifileucel for Melanoma: Lifileucel (Amtagvi) has received accelerated FDA approval for unresectable metastatic melanoma in adults previously treated with spec…
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Visit nascentmc.com/podcast for full show notes [free course] ChatGPT4 in medical writing and editing at learnAMAstyle.com Nascentmc.com for medical writing assistance for your CME or Medical Communications company. Eplontersen for ATTR-CM Eplontersen received FDA Fast Track designation for treating transthyretin-mediated amyloid cardiomyopathy (AT…
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ChatGPT4 in medical writing and editing at learnAMAstyle.com Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes Tricuspid Valve Replacement System for Tricuspid Regurgitation The FDA approved the Evoque tricuspid valve replacement system, a first in the U.S. for a transcatheter tricuspid d…
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Free course ChatGPT4 in medical writing and editing at learnAMAstyle.com · Nascentmc.com for medical writing assistance for your company.Visit nascentmc.com/podcast for full show notes Boxed Warning for CAR-T Cell Therapy: The FDA mandates a boxed warning on all CAR T-cell therapies due to increased secondary cancer risks, affecting six named treat…
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In this episode, we speak to Dr Emma Woodward and patient Nick Brown, about hereditary cancer predisposition, focusing on: · Li Fraumeni Syndrome (LFS), a rare cancer predisposing condition which gives a 70% lifetime risk of developing cancer, caused by germline mutations in the TP53 gene · Nick’s diagnosis with LFS syndrome and the affect this has…
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For the free course "ChatGPT4 for Medical Writers and Editors," go to learnAMAstyle.com Visit Nascentmc.com/podcast for detailed show notes and links. Erdafitinib for Urothelial Carcinoma: The FDA has fully approved erdafitinib (Balversa) for advanced or metastatic urothelial carcinoma with FGFR3 genetic alterations in adults. This follows its init…
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Visit nascentmc.com to get medical writing assistance for your company. Visit learnAMAstyle.com for free downloads about medical editing and writing in the AI era. See full write up and supporting links for this episode at nascentmc.com/podcast. Summary: § FDA has approved berdazimer topical gel, 10.3% (Zelsuvmi), as the first novel drug for mollus…
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Use Your Scientific or Medical Background in Medical Editing & Factchecking so you can supplement your income while working from anywhere on your own schedule. Visit learnAMAstyle.com for a free step-by-step checklist. Get immediate medical writing assistance from experienced, excellent, native-English speaking MD- and PhD-medical writers. Nascentm…
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Summary: Visit learnAMAstyle.com for the downloadable AMA Style cheat sheet Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's ep…
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For the AMA Style cheat sheet learnamastyle.com See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Test for Risk of Opioid Addiction:The FDA has approved AvertD by SOLVD Health, a test for assessing opioid addiction risk in individuals over 18, using genetic variants to evaluate addiction risk before prescr…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcastHere are the highlights: Belzutifan (Welireg) …
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: 1. Iptacopan (Fabhal…
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Summary: Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Nirogacesta…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: · Capivasertib (Truq…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: The FDA has approved…
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Summary: Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Pembrolizum…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: · Loqtorzi (toripali…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: BIMZELX (bimekizumab…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Velsipity (Etrasimod…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Novavax COVID Vaccin…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Ryzumvi (Phentolamin…
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In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from September 18, 2023 – September 22, 2023. Please check back every Monday morning so that you can stay up to date. Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Ass…
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In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from September 11, 2023 – September 15, 2023. Please check back every Monday morning so that you can stay up to date. See more details summaries and links to prescribing information at nascentmc.com/podcast Here are the highlights: • Ojjaara …
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In this episode, we speak to Corinne Faivre-Finn, a Professor of Thoracic Radiation Oncology about lung cancer clinical trials, focussing on: · Radiotherapy: what it is and how it’s used to treat lung cancers · Clinical trials: what are they, who are they for and how are they set up · The RAPID-RT clinical trial that launched at The Christie in ear…
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In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 28, 2023 – September 8, 2023. Please check back every Monday morning so that you can stay up to date. Here is information on the latest US FDA approvals, the week of August 28 – September 8, 2023. Check out our free downloads at n…
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Summary: In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 21, 2023 – August 25, 2023. Please check back every Monday morning so that you can stay up to date. See more details summaries and links to prescribing information at nascentmc.com/podcast Here are the highlights: FDA App…
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Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episodes at nascentmc.com/podcast · Elrexfio (elranatamab-bcmm) has received a…
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