FEATURE ARTICLES
FDA won't offer a waiver process or phased implementation. Instead, the agency is providing a seven-year runway to transition to a new labeling format.
- From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna
- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
- Where Contamination Control Really Breaks Down In Practice
- Trends In FDA FY 2025 Warning Letters
- Raising The Bar In Radiopharmaceutical Manufacturing
- SUS Interchangeability Assessment And Qualification Best Practices
- New MIT Consortium Links Innovation With Real-World Biomanufacturing
PHARMA ONLINE WHITE PAPERS
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![Isolated Antibody Drug Conjugates ADCs GettyImages-1438509824]( "Reducing ADC Timelines With Integrated Development And Manufacturing")
Reducing ADC Timelines With Integrated Development And ManufacturingADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.
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A Decade Of Transforming Pharmaceutical Manufacturing2/25/2026
Modern enzyme engineering, automation, and AI are reshaping therapeutic development — accelerating design, improving efficiency, and enabling faster, more sustainable biopharma manufacturing.
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Building The Business Case For LIMS1/21/2026
Explore how digital workflows and automation deliver measurable ROI and competitive advantage for life sciences organizations navigating complex manufacturing challenges.
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Alleviate Compliance Risks With Your EAM/CMMS3/2/2026
Discover how unified asset management enhances audit readiness by connecting maintenance, calibration, and quality insights, as well as how integrated workflows reduce compliance risk.
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Choosing The Right Platform: A Comparison For Regulated Industries2/22/2026
Regulated industries depend on tightly controlled review workflows, yet common tools rarely meet those demands. Explore how purpose‑built solutions strengthen compliance and help streamline timelines.
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Ready To Demystify Organoids?7/1/2025
Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Providing Packing And Blinding Solutions For An Innovative Drug Start-Up
- Fully Automated Cell Culture Passaging And Expansion
- Optimized Processes: A Guide To Lyophilization Cycle Development
- Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration
- Turnkey Dismantling, Modification, And Relocation Of A Multi-Glove Isolator System
NEWSLETTER ARCHIVE
- 03.19.26 -- A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
- 03.19.26 -- STREAM Edition: Closer To Home: Rethinking API Manufacturing
- 03.18.26 -- Struggling with mAb aggregation and other impurities?
- 03.17.26 -- Highlighting 50 Years of Excellence
- 03.16.26 -- Simplifying Complexity For Your Unique OSD Needs
INDUSTRY NEWS
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![FDA Logo on phone screen-GettyImages-2208861549]( "Høeg In, Pazdur Out At The FDA")
Høeg In, Pazdur Out At The FDAWhat 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.
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![business peope negotiating-GettyImages-637902194]( "9 Drugs Granted Fast Track By FDA's Voucher Program")
9 Drugs Granted Fast Track By FDA's Voucher ProgramWith 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.
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![Pharmaceutical sorting machine, pills-GettyImages-1499814881]( "Leaders In The Excipient Market: Region And Type")
Leaders In The Excipient Market: Region And TypeThough 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.
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![GettyImages-2189405678-GLP-1-obesity]( "Pfizer Strengthens Obesity Foothold With Metsera Acquisition")
Pfizer Strengthens Obesity Foothold With Metsera AcquisitionAfter discouraging efforts to bring two oral obesity drugs to market—danuglipron and lotiglipron—this acquisition launches Pfizer back into the obesity therapeutic game.
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![weight loss, diabetes, insulin pen-GettyImages-2196049931]( "FDA Cracks Down On GLP-1 Imports")
FDA Cracks Down On GLP-1 ImportsGLP-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
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.
More Content CollectionsSUPPLIER NEWS
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Axplora Announces $60 Million High Potency API Manufacturing Facility Expansion In Italy3/17/2026
Axplora, a global leader in complex active pharmaceutical ingredient (API) manufacturing, today announced a major milestone in its $60 million investment programme in highly potent API (HPAPI) manufacturing at its Farmabios site in Gropello Cairoli. The latest phase includes construction of a new 4,500 m², three-storey R&D and laboratory hub, designed to accelerate development, expand execution capacity and deliver cost-efficient high-potency manufacturing at scale.
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BD Announces $110 Million To Support U.S. Pharmaceutical Supply Chain For Biologic Drugs3/16/2026
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced a $110 million investment to expand its production of prefillable syringes, helping accelerate biologic and GLP-1 drug delivery and supporting pharmaceutical reshoring in the U.S.
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BD And Ypsomed Expand Partnership To Address Rapidly Growing Biologics Market3/16/2026
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Ypsomed, a leading developer of injection systems, are strengthening their collaboration with the development of a 5.5 mL version of the BD Neopak™ XtraFlow™ Glass Prefillable Syringe.
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ROSS PDDM-10 Planetary Dual Disperser Delivers Unmatched Pilot-Scale Processing Flexibility3/10/2026
The ROSS Model PDDM-10 Planetary Dual Disperser is a near-universal pilot scale mixer designed to deliver high shear and controlled planetary agitation under vacuum, enabling rapid solids dispersion and producing air-free, high-quality pastes, slurries, gels and putties. It can also handle powder blending, granulation and vacuum drying requirements. This mixer processes up to 12 gallons per batch with a full holding capacity of 15 gallons.
