ARTICLES BY KATIE ANDERSON
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FDA Launches PreCheck Program8/12/2025
The program introduces a two-phase approach to enable new U.S. drug manufacturing facilities: The Facility Readiness Phase and the Application Submission Phase.
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Gedatolisib Shatters Phase 3 Goals and Scales For Breast Cancer Breakthrough8/11/2025
After unprecedented phase 3 clinical trails of gedatolisib, Celcuity is working feverishly with its partners to get the drug ready to offer a new standard of care to those that suffer from advanced breast cancer.
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President Trump Demands MFN Prices In Manufacturer Letters8/7/2025
President Trump has sent out a letter to 17 major pharmaceutical manufacturers, asking them to commit to lower prices by Sept. 29, 2025, or he plans to deploy every tool in his arsenal to protect American families.
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Bristol Myers Squibb Forms Immunology Company With Finance Partner8/5/2025
The NewCo pipeline will start with three clinical-stage and two phase 1-ready investigational medicines that each target mechanisms in autoimmune diseases.
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George Tidmarsh Named CDER Director7/24/2025
Tidmarsh has over 30 years of experience in biotechnology, clinical medicine, and regulatory science and has authored 143 scientific publications and patents.
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Sanofi Expands Immunology Portfolio With Blueprint Acquisition7/24/2025
Sanofi expanded its portfolio in immunology with the completed acquisition of Blueprint Medicines Corporation.
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The 3 Big Barriers To AMT Implementation7/18/2025
Advanced manufacturing technologies (AMTs) can not only lower costs but also improve the quality and consistency of both API and final dosage manufacturing in pharmaceuticals, so why are they not more widely implemented?
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FDA Publishes 200+ CRLs For Increased Transparency7/16/2025
The letters were made available to increase transparency and help sponsors reduce similar mistakes in the future.
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Can AMTs Make U.S. Pharmaceuticals Faster, Better, Stronger?7/11/2025
As the pharmaceutical industry prepares for impending tariffs and invests in domestic manufacturing, advanced manufacturing technologies present a viable opportunity to modernize systems for improved efficiency, consistent quality and potentially lower costs.
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FDA Addresses U.S. Health Crisis With Voucher Program7/2/2025
FDA Commissioner Marty Makary, M.D., M.P.H., tapped into his oncologist experience to launch a new FDA program designed to fast-track the time it takes for important drugs to receive approval and get to patients.