# gene — RSS Amplifier Recent posts from the 49 feeds in the RSS Amplifier directory that cover gene. Page: Feed: --- ## [eSubmitter Application History](http://www.fda.gov/industry/fda-esubmitter/esubmitter-application-history) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ History of all updates to the application software in reverse chronological order by version number ## [FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia](http://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-patients-aged-8-years-and-older-glycogen-storage-disease-type-ia) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) as the first-ever treatment for adults and children 8 years of age and older with glycogen storage disease type Ia (GSDIa) ## [Biologics Electronic Reading Room (eFOIA)](http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-electronic-reading-room-efoia) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site. ## [ASCENIV](http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/asceniv) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Indicated for the treatment of Primary Immunodeficiency Diseases (PIDD) ## [Patient Listening Session Summaries](http://www.fda.gov/patients/fda-patient-listening-sessions/patient-listening-session-summaries) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions. ## [Memories of MAD: “If Famous Authors Wrote the Comics”](https://willfriedwald.substack.com/p/memories-of-mad-if-famous-authors) _2026-08-19 · Will Friedwald · Slouching Towards Birdland (Will Friedwald's SubStack)_ Another Bonus Mini Post: More stupid AI tricks ## [ELEVIDYS](http://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/elevidys) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. ## [Bold Faith – Part 8](http://mydestinychurch.com/sermons/2026/08/18/bold-faith-part-8/) _2026-08-19 · Destiny Church sermons_ August 16, 2026 [Listen](http://mydestinychurch.com/sermons/wp-content/uploads/2026-08-16.mp3) ## [Biologics PREA Reviews and Labeling Changes](http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-prea-reviews-and-labeling-changes) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under ## [FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing - 09/29/2026](http://www.fda.gov/vaccines-blood-biologics/workshops-meetings-conferences-biologics/fda-roundtable-strengthening-supply-chain-blood-manufacturing-09292026) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ On September 29, 2026, the Food and Drug Administration’s, Center for Biologics Evaluation and Research, Office of Blood Research and Review is hosting a roundtable on strengthening the supply chain for the collection and manufacturing of Whole Blood and blood components for transfusion and further manufacturing, including Source Plasma. ## [Meet Claude, the AI assistant (Sponsored)](https://crawlproof.com/a/Lxu6JfsEadoV) _2026-08-18 · **Sponsored**_ Conversational AI to answer questions, brainstorm ideas, and help with tasks. ## [Approved Cellular and Gene Therapy Products](http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Listing of licensed and approved products from the Office of Therapeutic Products (OTP). ## [EZPLAZ](http://www.fda.gov/vaccines-blood-biologics/blood-blood-products/ezplaz) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Freeze Dried Plasma ## [OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023 - 04/25/2023](http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otp-town-hall-gene-therapy-chemistry-manufacturing-and-controls-april-2023-04252023) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Tuesday, April 25, 2023. ## [OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023 - 06/08/2023](http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otp-town-hall-cell-therapy-chemistry-manufacturing-and-controls-june-2023-06082023) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This event will focus on cell therapy chemistry, manufacturing, and controls (CMC), including tissue-engineered medical products regulated by OTP, and will be a continuation of the December 2022 virtual town hall. ## [15-15 The Doomsday Machine and a Future Askew](https://thetrekfiles.trekfm.libsynpro.com/15-15-the-doomsday-machine-and-a-future-askew) _2026-08-18 · The Trek Files: A Roddenberry Star Trek Podcast_ Norman Spinrad's original March 1967 story outline for "The Planet Eater" introduced Star Trek to an unstoppable machine roaming the galaxy, consuming planets for fuel and leaving destruction in its wake. By the time it reached television, the story had a new title, "The Doomsday Machine," and became one of the most celebrated episodes of the original series. Author and filmmaker Jeffrey Morris… [Listen](https://dts.podtrac.com/redirect.mp3/traffic.libsyn.com/secure/thetrekfiles/15-15_Planet_Eater_outline.mp3?dest-id=631303) ## [New Strategies in Early ALS Detection](https://share.transistor.fm/s/b144667b) _2026-08-17 · Kevin Folta · Talking Biotech with Dr. Kevin Folta_ This episode explores the cutting-edge advancements in ALS diagnostics and treatment, highlighting how AI and digital health are transforming patient care and research. Guest Indo Navar shares her journey from Silicon Valley entrepreneurship to pioneering innovative solutions for ALS and other neurodegenerative diseases. [Listen](https://media.transistor.fm/b144667b/e9f07ca3.mp3) ## [70 YEARS AGO: Nat King Cole, Ella Fitzgerald, & Louis Armstrong—Two Days (and one night) in Los Angeles that shook the jazz world](https://willfriedwald.substack.com/p/70-years-ago-nat-king-cole-ella-fitzgerald) _2026-08-17 · Will Friedwald · Slouching Towards Birdland (Will Friedwald's SubStack)_ A Bonus Mini Post ## [Regulatory Harmonization and Convergence](http://www.fda.gov/vaccines-blood-biologics/international-activities/regulatory-harmonization-and-convergence) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Agency engages in a range of explicit harmonization initiatives, a subset of which includes the participation of CBER. ## [Exporting CBER-Regulated Products](http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/exporting-cber-regulated-products) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Division of Case Management (DCM) within CBER's Office of Compliance and Biologics Quality (OCBQ) directs and coordinates CBER's export programs, including review of requests for export of unapproved CBER-regulated products. ## [Tissue Establishment Registration](http://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Also, provided information on when to register update regist ## [Find it on Amazon (Sponsored)](https://crawlproof.com/a/7qZvuyEm2GMM) _2026-08-17 · **Sponsored**_ Open the Amazon product listing to see details and availability ## [Blood Establishment Registration and Product Listing](http://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65 ## [Collaborations and Partnerships](http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/collaborations-and-partnerships) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ CBER Research Collaborations and Partnerships ## [Vaccine Adverse Event Reporting System (VAERS) Questions and Answers](http://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-events/vaccine-adverse-event-reporting-system-vaers-questions-and-answers) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). ## [Vaccine Adverse Events](http://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/vaccine-adverse-events) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Information about the Vaccine Adverse Event Reporting System (VAERS), which is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to detect possible signals of adverse events associated with v ## [CYFENDUS](http://www.fda.gov/vaccines-blood-biologics/vaccines/cyfendus) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ For use as a post-exposure prophylactic vaccine following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial regimen. ## [Wrestling the Right Way | Joey Blaze](https://shows.acast.com/wrestlingmindset/episodes/wrestling-the-right-way-joey-blaze) _2026-08-17 · Wrestling Mindset_ Gene Zannetti talks with Purdue wrestler Joey Blaze about the mindset shift from freshman year, where he put unneeded pressure on himself as a higher-ranking recruit, to reframing wrestling as something he gets to do rather than has to do, staying level-headed after big wins to avoid the high that leads to the very next loss, how shifting his match evaluation from win or lose to did I do the right… [Listen](https://sphinx.acast.com/p/open/s/5aec535fe48f8bda3d66626d/e/6a82940f03af5e222aede256/media.mp3) ## [Drugs@FDA Data Files](http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) ## [August 2026](https://lexiventures.substack.com/p/august-2026) _2026-08-17 · Lexi Ventures · Lexi Ventures Newsletters_ AI at Lexi, An engineered virus, Turning a gene down, Experiments by robots, A living pesticide, Where the exits are ## [Protected: To Swim Among the Stars](https://logancollinsblog.com/2026/08/16/to-swim-among-the-stars/) _2026-08-17 · logancollins · LoganThrasherCollins.com_ There is no excerpt because this is a protected post. ## [Sudden Death Without Explanation in a Healthy 20-Year Old](https://robertchandler.substack.com/p/foreign-non-local-material-deposits) _2026-08-16 · Robert W. Chandler, MD MBA · Experimental Gene Therapy_ Case 152: SADS 1 = Found Dead, COF 4 = Unrelated Tissue Changes, COD 0 = Unrelated to Cause of Death, BNT162b2 180 and 141 days prior to death. ## [Zero-Persistence E2EE (Sponsored)](https://crawlproof.com/a/XCc0sT3P4qH2) _2026-08-16 · **Sponsored**_ End-to-end encryption with client-side WebCrypto and volatile memory. ## [Significant and Enlightening News Links 8/15/26](https://genevanshaar.substack.com/p/significant-and-enlightening-news-ed7) _2026-08-16 · Gene Van Shaar · Gene Van Shaar Substack_ Curated News Links by Gene Van Shaar (8/15/26) ## [Histopathological Analysis of COVID-19 Vaccine Induced Tissue and Organ Damage —Biodistribution, Organ Mapping, Cause of Death](https://robertchandler.substack.com/p/histopathological-analysis-of-covid) _2026-08-15 · Robert W. Chandler, MD MBA · Experimental Gene Therapy_ Burkhardt/Lang/Schwarz COVID-vaccine pathology series and Pfizer/BioNTech Study 185350 ## [The Human Proteome Was Never Finished](https://thepeptidelist.substack.com/p/the-human-proteome-was-never-finished) _2026-08-15 · The Peptide List · The Peptide List_ Scientists mapped HLA peptide evidence to 1,785 overlooked reading frames. The signal is real. Whether they are proteins remains unsettled. ## [Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting](http://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/human-cell-tissue-products-hctp-adverse-reaction-reporting) _2026-08-14 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting ## [Quiet time, Coffee time](https://jeanettegower.substack.com/p/coffee-time-ce4) _2026-08-14 · Jeanette Gower · Reflections on 50+ Years of Horse Breeding_ Great reviews are coming in ## [FLYING HOME! Jerry Leiber & Mike Stoller: Fathers of Vocalese?](https://willfriedwald.substack.com/p/flying-home-jerry-leiber-and-mike) _2026-08-14 · Will Friedwald · Slouching Towards Birdland (Will Friedwald's SubStack)_ They wrote about more than hound dogs and jailhouses—no, that's not all there is! ## [Small Fiber Neuropathy - POTS, long Covid, and more](https://geneticlifehacks.substack.com/p/small-fiber-neuropathy-pots-long) _2026-08-14 · Debbie Moon · Genetic Lifehacks_ Weekly Genetic Lifehacks Newsletter ## [What’s New for Biologics](http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics) _2026-08-14 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Latest news from the Center for Biologics Evaluation and Research ## [BioThrax](http://www.fda.gov/vaccines-blood-biologics/vaccines/biothrax) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ BioThrax is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age. ## [What does responsible breeding actually look like?](https://jeanettegower.substack.com/p/what-does-responsible-breeding-actually) _2026-08-13 · Jeanette Gower · Reflections on 50+ Years of Horse Breeding_ "I would like to breed a foal" ## [Commissioner's National Priority Voucher (CNPV) Pilot Program](http://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months. ## [Phase 1 Investigational New Drug (IND) Navigator](http://www.fda.gov/industry/phase-1-investigational-new-drug-ind-navigator) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise you need to prepare and submit an successful Investigational New Drug (IND) application. ## [FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development](http://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials. ## [CMC and GMP Guidances](http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/cmc-and-gmp-guidances) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This page lists CMC and GMP Guidance documents. ## [Recently Issued Guidance Documents](http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This page lists Recently Issued CBER and Cross-Center Guidance Documents. ## [Labeling for CBER-Regulated Products](http://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/labeling-cber-regulated-products) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Labeling for CBER-Regulated Products ## [Laboratory Information Bulletins](http://www.fda.gov/science-research/field-science-and-laboratories/laboratory-information-bulletins) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Laboratory Information Bulletins available to the public ## Curing Sickle Cell Before Life Begins _2026-08-13 · RARECast_ Sickle cell disease is caused by a single mutation in the beta-globin gene that leads to painful crises, anemia, and organ damage. Despite advances in treatment, it remains a devastating and often overlooked global health challenge, particularly in low-resource settings where children frequently go undiagnosed until life-threatening complications arise. The PERICLES project is an ambitious… [Listen](https://rss.art19.com/episodes/8ed1a96a-f60e-4ce9-b441-8ed3c53c8065.mp3?rss_browser=BAhJIhRSU1NBbXBsaWZpZXJCb3QGOgZFVA%3D%3D--6345a2e4a0991d4cbe92da92e0fa95ff9d12de2e) ## [Administrative Guidances](http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances) _2026-08-12 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This page lists Administrative Guidance documents. ## [Bold Faith – Part 7](http://mydestinychurch.com/sermons/2026/08/11/bold-faith-part-7/) _2026-08-12 · Destiny Church sermons_ August 9, 2026 [Listen](http://mydestinychurch.com/sermons/wp-content/uploads/2026-08-09.mp3)