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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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Wise Divine Women -Libido -Menopause -Breast Health, Oh My! The Unfiltered Truth for Christian Women

Dana Irvine Menopause Coach, Breast Health Educator, and Thermography Advisor

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Welcome to the Wise Divine Women Podcast! I'm Dana Irvine, your host, and guide on this journey of health, faith, and inner wisdom. As a Holistic Nutritionist, Breast Health Educator, and Women's Health Coach, I bring you expert insights, practical tips, and inspiring stories to empower you in every stage of life. Whether you're navigating menopause, enhancing breast health, or deepening your faith, this podcast is your space for growth and transformation. Get ready to live boldly, love deep ...
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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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Today I spoke with Dr. Alan Bauman, a leading hair surgeon, in Florida and New York. Dr Bauman shares his journey into the field of hair loss and restoration. He emphasizes the importance of a holistic approach to hair health, considering factors such as nutrition, lifestyle, and hormonal balance. Dr. Bauman discusses the role of genetics in hair l…
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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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Today I spoke with Shari Felsinger is a certified nutrition and mental wellness coach as well as an empty nest coach and author. She truly enjoys guiding people on their journey to live their very best. She has also written and published a book about her journey to releasing her adult kids out into the world. "Nobody Told Me It Would Be This Hard: …
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Today I spoke with Dr Sharon Surita, PhD, a Certified Functional Diagnostic Nutrition Practitioner and triumphant chronic illness warrior. Her passion for holistic well-being is shaped by her personal four-year journey to overcome challenges with dysautonomia and complications from a hernia mesh implant. Armed with a doctoral degree in Environmenta…
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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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Today I spoke with Teresa Trieb of She Breath. Teresa is a somatic breath therapist from Germany helping women gain access to their subconscious mind, release trapped emotions, and help rewire their brain through the power of transformational breathwork. Her success is having conquered her panic attacks, anxiety, and depression through breathwork. …
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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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Today I spoke with Christine MacCarroll is a Functional Nutritionist, Board Certified in Holistic Nutrition(TM), and a Certified Brain Health Professional. She’s also a woman with late-diagnosed ADHD, and mom to a daughter with ADHD. After helping her then-2-year-old daughter overcome a neurological speech disorder using nutritional therapy, she re…
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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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Emma Nicholls, the ‘Diabetic Duchess’ is a certified Health Coach and Food Scientist on a mission to support diabetics on their journeys to improved health and wellness. Emma has lived with Type One Diabetes for over 44 years and knows that the ownership of her longevity and well-being sits firmly in her hands. In her early 50s, Emma was faced with…
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Today on the Wise Divine Women Podcast I speak to Dr Diane Mueller, Lyme specialist and creator of MyLymeDoc.com take the quiz today! Today she offering this fabulous offer to our American Listeners. She writes: In order to heal from Lyme You Must Rewire Your Mind. Commonly, people are told that their pain, fatigue, brain fog, and strange symptoms …
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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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Today I spoke with Mary Ann Stenquist, Spending Coach who teaches women how to become unshoppable so they can afford the life they want with the money they already have. She teaches how to overcome the urge to shop by teaching why we shop and how to stop spending before it happens. She is passionate that all women deserve to find the money to not j…
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Welcome back to the Wise Divine Women Podcast today I discuss 5 Top Tips to help alleviate Breast Pain As discussed grab your ⁠How To Boost Your Estrogen Metabolism Checklist ⁠ Are you ready to gain a deeper understanding of menopause, breast health, and nutrition? Let's embark on a journey to embrace our new life with renewed energy, vitality, and…
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Welcome back to the Wise Divine Women Podcast today I discuss 5 Top Tips to help alleviate Breast Pain As discussed grab your How To Boost Your Estrogen Metabolism Checklist Are you ready to gain a deeper understanding of menopause, breast health, and nutrition? Let's embark on a journey to embrace our new life with renewed energy, vitality, and cl…
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Today we chat with Casey Kang Head, a 3x survivor of acute lymphoblastic leukemia & stroke survivor. Now a trauma-informed cancer coach who teaches survivors how to reclaim their lives and learn how to live healthier to ensure they are stronger physically, mentally & emotionally so they don’t live life in fear. Casey is the Author of “Finding Your …
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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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Today I speak to Rev. Christine Vaughan Davies who runs the hospital chaplaincy department at Robert Wood Johnson University Hospital. She is an ordained Presbyterian Minister, a Certified Educator with the Association of Clinical Pastoral Education, a Seminary Professor and a trained Spiritual Director. She earned her Master of Divinity degree fro…
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Today we continue learning about how nutrition plays a vital role in Breast and Hormone Health ⁠Part 1 ⁠ ⁠Part 2 ⁠ Part 3 Are you prepared to embrace the empowered woman you have become in this new phase of life? Are you ready to gain a deeper understanding of menopause, breast health, and nutrition? Let's embark on a journey to embrace our new lif…
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Today we continue learning about how nutrition plays a vital role in Breast and Hormone Health Part 1 Part 2 Are you prepared to embrace the empowered woman you have become in this new phase of life? Are you ready to gain a deeper understanding of menopause, breast health, and nutrition? Let's embark on a journey to embrace our new life with renewe…
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Today, I had a conversation with Heather Keeney, who is dedicated to empowering individuals by showcasing life's possibilities through her intense curiosity and active listening. This approach inspires people to explore new life directions and gain forward momentum. Heather's journey began in the helping professions as an addiction counselor and un…
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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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Today I talked with Deanna Marie, Life Coach. We have a moving and incredible discussion about alcoholism, marriage, boundaries and so much more. Her focus is to empower women in these difficult relationships and help them build confidence in themselves. We discussed that living with an Alcoholic is not easy! Let's Start Making Things Better Now. S…
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Today I had the great pleasure of speaking with DR. TOM O'BRYAN, a renowned functional medicine expert in environmental medicine and a leading voice in the field of holistic health and wellness. With an impressive career dedicated to uncovering the hidden impacts of environmental toxins on family health, Dr. O'Bryan offers invaluable insights into …
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Today we continue learning about how nutrition plays a vital role in Breast and Hormone Health. Part 1 Are you prepared to embrace the empowered woman you have become in this new phase of life? Are you ready to gain a deeper understanding of menopause, breast health, and nutrition? Let's embark on a journey to embrace our new life with renewed ener…
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Today on the Wise Divine Women Podcast I present a 5 part series onBalancing Hormones Through Nutrition: Strategies for Breast Health! Are you prepared to embrace the empowered woman you have become in this new phase of life? Are you ready to gain a deeper understanding of menopause, breast health, and nutrition? Let's embark on a journey to embrac…
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Today I talked to Carolyn Murphy of Firm Foundations. It was an incredible discussion on matters of trauma, purpose, and God. Carolyn J. Murphy is the Founder and CEO of Firm Foundations Community Outreach, LLC, a multifaceted organization established to aid individuals in navigating the aftermath of trauma. As a survivor and overcomer of childhood…
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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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The Wise Divine Women presents⁠ Cody Watkins⁠, a renowned online fitness coach with a compelling background that I'm confident will resonate with your audience. His journey from overcoming a life-threatening open heart surgery to becoming the "King of Transformation" is truly inspiring. On our podcast, Cody is enthusiastic about discussing his insi…
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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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Today we speak to Jamie Goudeau, a Christian author who was born and raised in a small community in south central Louisiana—the heart of Cajun country. Jamie is the blessed wife of her husband, best friend, and biggest fan, Brent Goudeau. She has four adult children and one bonus child and is the proud grandmother of six grandchildren, who are a la…
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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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Today on the Wise Divine Women Podcast I spoke with Patrice Malloy of The Malloy Group Inc. She is a spark of joy and has immense intelligence when it comes to helping women in this journey of starting a business with a holistic approach to finances. Malloy Management Group is a boutique financial advisory and consulting firm that empowers women in…
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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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Welcome back to the Wise Divine Women Podcast, today we speak to Ann Maria Tom and Anoop Asok! So wonderful to speak to fellow Canadians based out of British Columbia. Together as a dynamic duo, they help women overcome hormonal imbalances and emotional eating through the powerful Metabolic Mastery Method. Both Anna Maria and Anoop have over a deca…
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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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The Wise Divine Women presents Cody Watkins, a renowned online fitness coach with a compelling background that I'm confident will resonate with your audience. His journey from overcoming a life-threatening open heart surgery to becoming the "King of Transformation" is truly inspiring. On our podcast, Cody is enthusiastic about discussing his insigh…
  continue reading
 
The Wise Divine Women Podcast presents Catherine Darley, ND, of the Institute of Naturopathic Sleep Medicine, Inc. Today we spoke about sleep and its importance during menopause. She gave us some incredible insight and offered some tips and tricks for better sleep. Please check out all her offerings: Courses: SkilledSleeper Course: TransformYour Sl…
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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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Today on the Wise Divine Women Podcast, I had the special opportunity to speak with Dr Cat Brown. Dr. Cathleen Brown is a board-certified OB/GYN and a native of Philadelphia, Pennsylvania. She graduated from the Philadelphia College of Osteopathic Medicine in 2004. After completing her residency training at the Tripler Army Medical Center in Hawaii…
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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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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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