Xtalks Webinars

Zeto has won FDA 510(k) clearance for New Wave, a portable EEG system designed for outpatient and at-home use aimed at reducing wait times and expanding access to brain monitoring. Read more at buff.ly/gtXcuWg. #FDA #MedTech #Neurotech

Baebies’ FINDER platform received FDA clearance + CLIA waiver. The system features PCR-quality molecular testing at the point of care, delivered in minutes. Read more at buff.ly/J3nEDKu. #Diagnostics #MedTech #PointOfCare #MolecularDiagnostics

April is Parkinson’s Awareness Month, and April 11 is World Parkinson’s Day, a complex, progressive disease that affects millions worldwide and that is on the rise. From breakthrough research to patient advocacy, momentum is building. Read more at buff.ly/L4PNuDW. #ParkinsonsAwarenessMonth #ParkinsonsDisease #ParkinsonsAwareness #WorldParkinsonsDay #Neurodegeneration

The FDA has approved Lynavoy (linerixibat) for cholestatic pruritus in primary biliary cholangitis (PBC), marking the first therapy specifically targeting the debilitating condition characterized by severe itch. Read more at buff.ly/CtIyo95. #PBC #FDA #RareDisease #Hepatology

Join us to slash your release cycles and move beyond the months-long wait for regulatory approvals with Jenn Dixon and Adrian Samsel in this on-demand webinar hosted by Ketryx. Learn how to turn the regulatory "waiting game" into a streamlined release cycle by mastering Predetermined Change Control Plans (PCCPs) for your AI and software updates. You’ll walk away with a clear blueprint for integrating automated validation into your CI/CD pipeline, allowing you to stay ahead of model drift and compliance hurdles without slowing down your innovation. Access these key insights and more now: buff.ly/bqK82Km #Ketryx #MedicalDevices #PCCP #SaMD #AIinHealthcare #MachineLearning #SoftwareValidation #CICD #RegulatoryAffairs #MedTech #QualityManagement #FDACompliance #SoftwareAsAMedicalDevice #OnDemand

Master the complex co-development of targeted therapies and companion diagnostics with Sumitra Smith, Khaled Tolba, MD, and Cori Ragan in this webinar hosted by Fortrea. As precision medicine shifts into earlier-line and adjuvant settings, the stakes for integrating liquid biopsy and ctDNA strategies have never been higher. Register now to navigate the critical intersection of medical, regulatory, and operational strategy and learn how to operationalize precision oncology at scale: buff.ly/581atdY #Fortrea #PrecisionOncology #CompanionDiagnostics #CDx #LiquidBiopsy #ctDNA #OncologyTrials #RegulatoryAffairs #IVDR #ISO20916 #Biotech #ClinicalOperations #TargetedTherapy #CancerResearch

Layoffs are continuing to hit pharma and biotech at a steady pace. From layoffs at Takeda and Amgen to bankruptcies among smaller biotechs, companies are tightening their grip on cash flows amid continuing economic, technological and geopolitical uncertainty. Read more at buff.ly/L4RYfuo. #PharmaLayoffs #BiotechLayoffs

Mammotome has secured FDA clearance for an industry-first in-room MR breast biopsy system designed to aid faster workflows, improved precision and better patient experience in MRI-guided breast biopsies. Read more at buff.ly/vbnRoW6. #Biotech #MedTech #BreastCancer #Radiology #FDA #Diagnostics

Novo Nordisk is cutting ~400 jobs at its former Catalent site in Bloomington, Indiana, amidst ongoing manufacturing challenges despite efforts to stabilize operations. Read more at buff.ly/J1MRIsZ. #pharma #layoffs #manufacturing

The FDA has approved Yuviwel, the first once-weekly treatment for children with achondroplasia aged 2 years and older. The FGFR3-targeting therapy offers a new option for the rare genetic condition. Read more at buff.ly/WQbNjl5. #RareDisease #Pediatrics #FDAApproval #Achondroplasia

CSL is investing $1.5B to expand plasma therapy manufacturing in the US at its Kankakee, Illinois, site. The investment adds to the company’s $3 billion spending on US manufacturing since 2018. Read more at buff.ly/c5eMbvo. #Biotech #PlasmaTherapy #CSL #PharmaManufacturing

AstraZeneca’s IL-33 antibody tozorakimab delivers a “double win” in two Phase III trials, cutting exacerbations across a broad patient population. With the latest results, the candidate has beaten competitors from Roche and Sanofi/Regeneron. Read more at buff.ly/p9NWIGi. #COPD #ClinicalTrials #AstraZeneca

The FDA has approved Lynavoy (linerixibat) for cholestatic pruritus in primary biliary cholangitis (PBC), marking the first therapy specifically targeting the debilitating condition characterized by severe itch. Read more at buff.ly/CtIyo95. #PBC #FDA #RareDisease #Hepatology

The FDA has approved Eli Lilly’s highly awaited oral GLP-1 obesity pill Foundayo (orforglipron). The approval comes just a couple of months after rival Novo Nordisk received an FDA nod for its Wegovy pill. Read more at buff.ly/VcZBUg7. #FDA #FDAApproval #Obesity #WeightLossDrug #GLP1Drugs

Vote in our latest Xtalks Life Science Poll: As the pharma industry evolves, demand is growing for talent across AI, clinical development, regulatory affairs and manufacturing. Which roles will be most in demand over the next five years? Cast your vote and see results at buff.ly/UDYyOQg #PharmaJobs #LifeSciences #Biotech #ClinicalResearch #RegulatoryAffairs #AI #Biomanufacturing

Join us to evolve your risk management from a compliance checkbox into a high-value strategic asset with Dmitri Berman in this webinar hosted by Premier Research. While nearly every modern trial now incorporates some element of Risk-Based Quality Management (RBQM), the real challenge lies in building a holistic, cross-functional framework that drives long-term operational value rather than just meeting minimum regulatory requirements. Register now to discover the core elements of a mature RBQM strategy, explore real-world results from a central monitoring assessment case study, and learn practical approaches for overcoming implementation hurdles: buff.ly/Zsxq3MQ #PremierResearch #RBQM #RiskBasedMonitoring #ClinicalOperations #ClinicalTrials #DataIntegrity #PatientSafety #CentralMonitoring #DrugDevelopment #Biotech #TrialEfficiency #QualityManagement

Strengthen your respiratory data integrity and navigate the complexities of modern clinical trial execution with Dr. Todd Lustine, Kevin McCarthy, Martha Mathews Martin, and Phil Lake in this webinar hosted by Clario. They will explore how centralized oversight and risk-based monitoring (RBM) address the unique challenges of data variability and test-dependent reliability in respiratory drug development. Learn how to elevate protocol compliance and build a robust foundation for high-quality pulmonary function data across your global study sites: buff.ly/mlveGX8 #Clario #RespiratoryResearch #ClinicalTrials #Spirometry #DataIntegrity #ClinicalOperations #RBM #PulmonaryMedicine #DrugDevelopment #FDACompliance #TrialExecution #QualityAssurance #LifeSciences

Meet Xtalks Featured Community Member Rehana Anjum, PhD, Scientist at CRAMSN Research Park. Through scalable process development and sustainable chemistry, she is helping ensure pharmaceutical innovation is both effective and environmentally responsible. Read more at buff.ly/ofwsKDP. #CDMO #ProcessChemistry #SustainablePharma #GreenChemistry #PharmaManufacturing #XtalksCommunity

As biologics pipelines grow in complexity, upstream media strategy is becoming critical to manufacturing success. In this special 250th episode of the Xtalks Life Science Podcast and Breakthrough episode with Dr. Corey Stanton, Omar Wahab of Lonza explains how structured media development can help organizations accelerate timelines and strengthen supply resilience. Listen now at buff.ly/zH4698S.

On World Health Day 2026, the WHO is encouraging people to stand with science and engage in collective efforts to improve health for all. From scientific innovations to widening global health gaps, the future of healthcare depends not just on breakthroughs, but on equitable access. Read more at buff.ly/Gh8imED. #StandWithScience #WorldHealthDay #GlobalHealth #PublicHealth #HealthEquity