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 Approves Tyruko as First Biosimilar to TysabriThe FDA approved Tyruko as the first biosimilar to Tysabri for treating relapsing forms of MS in adults. It has similar risks and side effects as Tysabri and is also approved for treating certain Crohn’s Disease patients. The product is available from Sandoz Inc. Source Abrysvo RSV Maternal Immunization ApprovedThe FDA approved Abrysvo, a vaccine for preventing respiratory disease caused by RSV in infants through maternal immunization. The approval is based on Phase 3 MATISSE trial results. Abrysvo was also approved for older adults earlier this year. Source sBLA Filed for Rybrevant in Advanced NSCLCAn sBLA was filed for expanded approval of Rybrevant, combined with certain drugs, for treating advanced non–small cell lung cancer with EGFR exon 20 insertion mutations. The approval was granted to Janssen Pharmaceuticals. Source Priority Review of Xtandi in Early PCaXtandi received Priority Review by the FDA for an expanded use in early-stage prostate cancer. The sNDA is based on a Phase 3 EMBARK trial, where Xtandi showed significant benefits. The product is manufactured by Pfizer, Inc.  Intro and outro music Garden Of Love by Pk jazz Collective    

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 accelerated approval for the treatment of adult patients with relapsed or refractory multiple myeloma who have undergone multiple prior therapies. Elrexfio is a subcutaneously delivered bispecific antibody (BsAb) immunotherapy activating T-cells to kill myeloma cells. Approval is contingent upon verification of clinical benefit in further trials. The approval was granted to Pfizer. Elrexfio joins other bispecific antibody therapies from Janssen for the same condition. ·      The FDA has approved the Hepzato Kit for delivering melphalan to the liver as a treatment for metastatic uveal melanoma (mUM) with unresectable hepatic metastases. This is the only liver-directed therapy approved for this purpose. Approval was based on the FOCUS Study (NCT02678572). The manufacturer, Delcath Systems, intends to explore broader applications beyond uveal melanoma due to the therapy's potential for other tumor types. ·      A higher-dose version of Eylea (aflibercept) injection has been FDA-approved for treating wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). This approval is based on PULSAR and PHOTON pivotal trials demonstrating non-inferior vision gains at longer dosing intervals compared to the standard dose. Eylea is a VEGF inhibitor, approved for wet AMD in 2011. The approval was granted to Regeneron Pharmaceuticals. ·      Ingrezza (valbenazine) capsules have gained FDA approval for treating chorea associated with Huntington's Disease (HD). The approval is supported by clinical studies and was granted to Neurocrine Biosciences. Ingrezza was previously approved for tardive dyskinesia. ·      The FDA has approved Sohonos (palovarotene) to treat fibrodysplasia ossificans progressive (FOP), a rare bone disease causing heterotopic ossification. The approval is based on Phase 3 MOVE trial results, showing effective reduction in bone growth. Sohonos is selective for a subtype of retinoic-acid receptors. It received Orphan Drug and Breakthrough Therapy Designations and is manufactured by Ipsen. ·      Veopoz (pozelimab-bbfg) has gained FDA approval as the first treatment for CD55-deficient protein-losing enteropathy (CHAPLE disease). CHAPLE disease is a rare inherited immune disorder causing complement hyperactivation. Veopoz is a complement inhibitor indicated for patients aged 1 year and older. It received multiple designations and was granted approval to Regeneron Pharmaceuticals. Intro and outro music Garden Of Love by Pk jazz Collective Let us know if we can help with any medical writing!  

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 In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 7, 2023 – August  11, 2023.  Please check back every Monday morning so that you can stay up to date.  Here are the highlights: ·      The FDA has approved Akeega, a combination of niraparib (PARP inhibitor) and abiraterone acetate (anti-androgen), as the first orally administered treatment for BRCA-positive metastatic castration-resistant prostate cancer. The approval was based on the MAGNITUDE study showing improved progression-free survival with the addition of niraparib. ·      Talvey (talquetamab-tgvs), a bispecific T-cell engaging antibody, has received accelerated approval for patients with relapsed or refractory multiple myeloma who have undergone multiple previous therapies. ·      Izervay (avacincaptad pegol intravitreal solution), a complement C5 inhibitor, has gained FDA approval for use in geographic atrophy related to age-related macular degeneration, and showed a significant reduction in disease progression. ·      Boston Scientific's POLARx Cryoablation System has been approved for treating paroxysmal atrial fibrillation, demonstrating effectiveness in reducing paroxysmal atrial arrhythmias in the FROZEN-AF IDE clinical trial.  The full writeups are available here: https://nascentmc.com/podcast/ Intro and outro music Garden Of Love by Pk jazz Collective

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 In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from July 31, 2023 – August  4, 2023.  Please check back every Monday morning so that you can stay up to date.  Here are the highlights: ·      The FDA has approved Zurzuvae, the first oral medication for postpartum depression, showing significant improvement in patient symptoms compared to placebo groups. ·      Jemperli, a PD-1 inhibitor, has been approved by the FDA for use with chemotherapy in adult patients with primary advanced or recurrent endometrial cancer with specific mutations. The drug is already approved for use as a single agent in similar cases and is now indicated for use in the first-line setting, with discussions for a broader indication underway with the FDA. ·      The FDA has approved the oral drug Lonsurf, in combination with bevacizumab, for the treatment of adult patients with metastatic colorectal cancer previously treated with specific chemotherapy and targetd therapies. Lonsurf, initially approved as a single agent in 2015, is also approved for advanced metastatic gastric or gastroesophageal junction adenocarcinoma. ·      The FDA has approved an expanded indication for Ervebo, a vaccine now indicated for the prevention of disease caused by Zaire ebolavirus for individuals aged 12 months and older.  Did you know, you can access our nascentmc.com/podcast page and search the notes from this podcast! So for example, if you search a term like "diabetes" it will bring up all the diabetes related therapeutic agents approved since the first episode on May 15 of this year. We're also including the prescribing information with each summary too. Check it out at nascentmc.com/podcast. Intro and outro music Garden Of Love by Pk jazz Collective  

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 Here is information on the latest US FDA approvals, the week of July 24 –  July 28, 2023. Just to summarize up front, we have RiVive receiving other the counter approval for opioid overdose; Balfaxar for urgent reversal of warfarin (VKA) therapy; Xdemvy for a common eyelid condition, Demodex blepharitis. PDUFA dates this week: Remestemcel-L for acute GVHD and zuranolone for major depressive disorder and postpartum depression.  Here are the highlights: ·       RiVive (naloxone hydrochloride nasal spray) has been approved by the FDA for over-the-counter use to treat known or suspected opioid overdose, rapidly reversing opioid effects and restoring normal respiration. This approval marks the second nonprescription naloxone product, the other being Narcan. ·       Balfaxar® (prothrombin complex concentrate, human-lans) has received FDA approval for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adult patients requiring urgent surgery or invasive procedures. Balfaxar® replenishes deficient clotting factors caused by warfarin therapy and was supported by the LEX-209 clinical trial, demonstrating hemostatic efficacy and non-inferiority to a comparator, Kcentra®. The medication includes a boxed warning for thromboembolic event risk. ·       XdemvyTM (lotilaner ophthalmic solution 0.25%) has been approved by the FDA as the first treatment for Demodex blepharitis, targeting inflammation caused by Demodex mites. Administered as an eye drop, Xdemvy eradicates the mites over six weeks, providing relief for patients with eyelid inflammation and discomfort. The treatment was well-tolerated, with common adverse reactions being eye stinging and burning in about 10% of patients. ·       Upcoming PDUFAs Remestemcel-L, being developed for acute graft versus host disease (aGVHD), has a PDUFA date of August 2. Derived from mesenchymal stromal cells, it may treat this life-threatening complication of bone marrow transplants. Currently, there are no approved treatments for steroid-refractory aGVHD in children under 12, making Remestemcel-L a potential solution. Zuranolone (SAGE-217) has a PDUFA date of August 5 for major depressive disorder and postpartum depression. This potential treatment, a positive allosteric modulator of GABA-A receptors, aims to rebalance dysregulated neuronal networks to help reset brain function in people with depression.  Intro and outro music Garden Of Love by Pk jazz Collective  

 In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from July 17, 2023 – July 21, 2023.  Please check back every Monday morning so that you can stay up to date.  Here are the highlights:   Vanflyta® for FLT3-ITD+ AML The FDA has approved Vanflyta (quizartinib), developed by Daiichi Sankyo, for treating adult patients with acute myeloid leukemia (AML) having the FLT3-ITD mutation. The approval came after data from the QuANTUM-First trial showed improved overall survival rates when Vanflyta was added to treatment. This makes Vanflyta the third drug approved for FLT3-positive AML, joining Novartis' Rydapt® and Astellas Pharma's Xospata®.   BeyfortusTM for RSV AstraZeneca's BeyfortusTM (nirsevimab) has been approved by the FDA for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in neonates, infants, and children up to 24 months of age. The approval was supported by data from three clinical trials, and the drug has also been given a fast-track designation. Beyfortus becomes the second antibody available for RSV protection in young children, following palivizumab or Synagis®. Cyfendus Anthrax Vaccine The FDA has approved CyfendusTM (Anthrax Vaccine Adsorbed, Adjuvanted) for post-exposure prophylaxis following exposure to Bacillus anthracis, the bacterium causing Anthrax, in adults aged 18 to 65. The vaccine is administered in two doses, two weeks apart, and clinical trials have found it to be non-inferior to the already available BioThrax® vaccine. Cyfendus has been in use since 2019 under a pre-emergency use authorization. YcanthTM for Molluscum Contagiosum The FDA has approved Verrica Pharmaceuticals' YcanthTM (cantharidin) topical solution for treating molluscum contagiosum in patients aged 2 and older. The approval is based on results from two identical phase 3 trials involving over 500 patients. Despite being available via compounding sources for years, Ycanth is the first FDA-approved standardized product for molluscum contagiosum. This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit Nascent Medical. Intro and outro music Garden Of Love by Pk jazz Collective

In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from July 10, 2023 – July 14, 2023.  Please check back every Monday morning so that you can stay up to date.   Get our free download! Implementing AMA Style – 8 Things to Get Right  Here are the highlights of this week's episode: Opill® is the first over-the-counter birth control pill approved by the FDA, containing norgestrel tablets as a progestin-only contraceptive. Opill® thickens cervical mucus, prevents the release of eggs, and thins the uterine lining to provide effective contraception. Opill® will be available in stores in the US in early 2024 Leqvio® (inclisiran) has received FDA approval for expanded use in patients with elevated LDL-C and increased risk of heart disease, in addition to its previous indications. The drug is an RNA therapy that lowers LDL-C levels and is administered via a single subcutaneous injection initially, followed by repeat doses every 3 and 6 months. Clinical studies showed a mean reduction of approximately 50% in LDL-C levels; common adverse reactions are injection site reactions, arthralgia, and bronchitis. Takeda has withdrawn its Biologics License Application for the Dengue vaccine candidate, TAK-003, following FDA's request for additional data not included in the application. TAK-003, also known as Qdenga®, is already approved in various countries. Dengue is a mosquito-borne disease causing significant illness and deaths worldwide; currently, there are limited vaccines or other preventive agents available. This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit nascentmc.com Intro and outro music Garden Of Love by Pk jazz Collective

Get our free download! Implementing AMA Style – 8 Things to Get Right Here are the highlights of this week's episode: ·      The FDA granted traditional approval to Leqembi, an Alzheimer's treatment manufactured by Eisai and Biogen. The approval, based on phase 3 data demonstrating reduced cognitive decline in early Alzheimer's patients, makes Leqembi the first approved drug in its class, offering new treatment possibilities for the 6.5 million Alzheimer's patients in the US. ·      Abbott's Aveir™ DR Dual Chamber Leadless Pacemaker is the first dual chamber leadless pacemaker system for individuals with abnormal or slow heart rhythms. Utilizing the body's natural conductive properties, the device offers more efficient battery usage compared to other communication technologies and reduces the risk of complications associated with traditional pacemakers due to its minimally invasive implantation procedure. ·      The FDA approved a liquid formulation of the cancer drug cyclophosphamide. The new formulation, manufactured by Nevakar, is available in two doses and offers advantages over current powdered forms, including increased stability and reduced risk of dosing errors. ·      Amneal Pharmaceuticals received a Complete Response Letter from the FDA regarding IPX203 for Parkinson's disease. While this extended-release formation of carbidopa/levodopa shows promise with more effective therapeutic benefits than current formulations, the FDA requested additional safety information on a component of the drug, carbidopa. Amneal will continue working with the FDA to address its concerns. Please check back every Monday morning for last week's approvals so that you can stay up to date.  Visit our podcast page here. This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit nascentmc.com Intro and outro music Garden Of Love by Pk jazz Collective  

Get our free download! Implementing AMA Style – 8 Things to Get Right In this episode, we discuss the latest FDA approvals from June 26 –  June 30, 2023.          Lantidra (donislecel-jujn) has been FDA approved for the treatment of type 1 diabetes. Lantidra is an allogeneic pancreatic islet cellular therapy derived from deceased donor pancreatic cells.        Ngenla (somatrogon-ghla) has been approved by the FDA for the treatment of pediatric growth hormone deficiency. It is administered through weekly injections and is the second long-acting agent approved for use in children.        Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy based on an adeno-associated virus vector, has received FDA approval for the treatment of severe hemophilia A in adults. It is administered as a one-time intravenous infusion.        Rystiggo (rozanolixizumab-noli) has been granted FDA approval for the treatment of generalized myasthenia gravis (gMG) in adult patients who are positive for certain antibodies. It is a subcutaneous infusion of a humanized monoclonal antibody.        Skyclarys (omaveloxolone) is the first FDA-approved treatment for Friedreich's ataxia. It is now available for patients aged 16 years and older.        Atorvaliq (atorvastatin calcium) is the first FDA-approved liquid suspension of atorvastatin for the treatment of high cholesterol and risk factors for heart disease and stroke. Please check back every Monday morning for last week's approvals so that you can stay up to date.  This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit nascentmc.com Intro and outro music Garden Of Love by Pk jazz Collective

Get our free download! Implementing AMA Style – 8 Things to Get Right In this episode, we discuss the latest FDA approvals from June 19 –  June 23, 2023.  Here are the key highlights: ·       The FDA has given approval to Pfizer's Talzenna and Xtandi for treating metastatic castration-resistant prostate cancer in adults with certain genetic mutations. The approval came following successful Phase 3 TALAPRO-2 trial results. ·       Sarepta Therapeutics' Elevidys, a gene therapy for Duchenne muscular dystrophy, has received accelerated approval from the FDA. Elevidys, the first gene therapy of its kind, is approved for ambulatory pediatric patients aged 4-5 years with confirmed mutation in the DMD gene. ·       Jardiance and Synjardy, initially approved for adults in 2014 and 2015 respectively, have now been approved by the FDA for use in children aged 10 and older with type 2 diabetes. This approval came on the back of the DINAMO phase 3 trial results. ·       Pfizer’s Litfulo, a once-daily oral treatment for severe alopecia areata for individuals aged 12 and older, has received FDA approval. This is the first treatment approved for adolescents with this condition.  ·       Amgen's Blincyto has received FDA approval for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease. This moves the drug from an accelerated approval to a full approval status. ·       Argenx's Vyvgart Hytrulo, a subcutaneous version of the original drug Vyvgart, has been approved by the FDA. It is indicated for generalized myasthenia gravis (gMG) in adult patients who test positive for anti-acetylcholine receptor antibodies. ·       Bayer's Ultravist (iopromide) injection, the first contrast agent for contrast-enhanced mammography, has been approved by the FDA. This new imaging tool enhances visibility of suspected or known breast lesions. ·       The FDA has refused to grant accelerated approval to Intercept Pharmaceuticals' drug obeticholic acid (OCA) for treating non-alcoholic steatohepatitis (NASH). This is the second time the FDA has declined to approve the drug for NASH due to potential risks. ·       Please check back every Monday morning for last week's approvals so that you can stay up to date.  See all the episodes here. ·       This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit nascentmc.com  ·       Intro and outro music ·       Garden Of Love by Pk jazz Collective