PHARMA ONLINE WHITE PAPERS

  • Unpacking FDA's Final Rule To Regulate LDTs

    Discover how the FDA's rule redefines diagnostic testing by classifying laboratory-developed tests (LDTs) as medical devices to ensure stricter oversight and consistent standards for safety and efficacy.

  • A Journey To Boundless Automation In Life Sciences
    7/1/2025

    Boundless automation reimagines industrial computing through seamless integration of the intelligent field, edge, and cloud, unified by a real-time data fabric that enables digital transformation.

  • Exploring The Potential Of Agentic AI
    8/12/2025

    Discover how agentic AI is poised to transform Enterprise Asset Management in regulated industries to enhance compliance, reduce downtime, and bridge fragmented systems for resilient operations.

  • The Evolution Of Antibody-Drug Manufacturing
    6/3/2024

    Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.

  • Advances In Regulations For Viable Environmental Monitoring
    2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  • Why Biopharma Breakthroughs Aren't Moving The Market
    10/20/2025

    Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.

Katie-Anderson-Chief-Editor

INDUSTRY NEWS

  • Høeg In, Pazdur Out At The FDA

    What an eventful week it has been at the FDA, with Richard Pazdur, M.D., resigning after weeks in his position as director of Center for Drug Research and Evaluation (CDER), and his vacancy being quickly filled by acting director Tracy Beth Høeg, M.D.

  • 9 Drugs Granted Fast Track By FDA's Voucher Program

    With targets like pancreatic cancer, deafness, blindness, infertility and vaping addiction, these drugs were chosen due to an unmet need, addressing a public health crisis, boosting domestic manufacturing or increasing affordability.

  • Leaders In The Excipient Market: Region And Type

    Though North America led the market with a 38.32% market share of $3.15 billion in 2024, Asia Pacific is expected to have the fastest growth in the upcoming years.

  • Pfizer Strengthens Obesity Foothold With Metsera Acquisition

    After discouraging efforts to bring two oral obesity drugs to market—danuglipron and lotiglipron—this acquisition launches Pfizer back into the obesity therapeutic game.

  • FDA Cracks Down On GLP-1 Imports

    GLP-1 bulk drug substances must be detained without physical examination (DWPE) unless they are on a list (Green List) of approved foreign GLP-1 manufacturers.

PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

MilliporeSigma Pharm Online Ebook

 

Explore how sterility assurance, including sterilization validation and environmental monitoring, is essential for controlling microbial contamination in mammalian cell production to ensure patient safety. Check out the latest e-book from Pharmaceutical Online.

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