Lorraine Collings’ Post

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

FDA Drug Information Soundcast in Clinical Oncology (DISCO) is an FDA podcast series that provides information about: ☑️ new product approvals ☑️ emerging safety information for cancer treatments ☑️ other current topics in cancer drug development 🎧 https://lnkd.in/gGubiqrV #InternationalPodcastDay

There's a significant trend in cancer treatment that you might have missed… This year, the FDA is expected to approve three new Antibody-drug conjugates (ADCs) for commercial use. With 15 on the market and over 100 cleared for clinical trials, this trend in oncology is driving eye-watering M&A investment by big pharma (as explained in Asmita S.'s January article on the trend).  But what exactly are ADCs? How do they work and why are so many in the sector banking on ADCs as the future of cancer treatment? #Primerli explains in the latest Pharma Trends primer! #newsincontext #healthcareindustry

The FDA’s Accelerated Approval process has transformed cancer treatment timelines, providing a beacon of hope to patients in their toughest battles. With controversies surrounding drugs like aducanumab and regulatory shifts, we’re delving into what this signifies for the future of pharma. Join the conversation with Ross Maclean and Michael Glover in PharmaLive to explore the full article’s insights. #FDA #oncology #acceleratedapprovals #biopharma #FDAapproval #Patientoutcomes PRECISIONvalue PRECISIONheor PRECISIONadvisors