FEATURE ARTICLES
MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.
- FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs
- Leveraging Historical Data to Accelerate Process Understanding
- Fostering A Quality Software Culture
- Lessons In Quality From Sanofi's Plai.qa
- Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
- Here's What You Need To Know About The Access Consortium Pathway
- Is Charisma An API?
PHARMA ONLINE WHITE PAPERS
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Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know
This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.
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The GxP Digital Maturity Model8/8/2025
Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.
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Maximize Your Laboratory Efficiency10/20/2025
Gain insight into how labs can boost productivity by reducing downtime, minimizing errors, and increasing walk-away time through real-time insights and analytics.
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FT-IR Identifies Contaminants And Helps Avoid Hazards And Product Loss3/7/2024
Fourier Transform Infrared Spectroscopy (FT-IR) is a reliable method with multiple applications when it comes to identifying both intrinsic and extrinsic compounds in a drug product.
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Advancing Multiomics Through Intelligent Automation10/27/2025
Modern automation tackles hidden pipetting errors and boosts reproducibility. Discover how your lab can scale confidently, reduce rework, and accelerate multiomic workflows with built-in traceability.
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Epigenetics Application Guide10/2/2024
To fully understand biology and disease mechanisms, it is crucial to explore the role of epigenetic factors. Explore how epigenetic regulation works and methods to study these essential components.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 12.14.25 -- Shaping The Future Of GLP-1 Quality
- 12.13.25 -- Pharmaceutical Online Best Of November
- 12.13.25 -- Comprehensive Solutions And Services For Pharma Facilities And Cleanrooms
- 12.11.25 -- Simplify Your ADC Development And Manufacturing Journey
- 12.11.25 -- Innovation, Growth (And Happiness) Projected For Pharma
INDUSTRY NEWS
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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.
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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.
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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.
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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.
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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
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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$6B Commitment: Eli Lilly Expands U.S. Manufacturing With New Huntsville Facility12/10/2025
Eli Lilly and Company (NYSE: LLY) today announced plans to invest more than $6 billion in a new manufacturing facility in Huntsville, Alabama. This next-generation synthetic medicine active pharmaceutical ingredient (API) facility, the third of four new U.S. sites Lilly plans to announce, will produce small molecule synthetic and peptide medicines.
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Bora Pharmaceuticals And Corealis Pharma Forge Strategic Alliance To Deliver Seamless, End-To-End Oral Solid Dose Development12/9/2025
Bora Pharmaceuticals Co., Ltd. (“Bora”, TWSE: 6472), a global leader in pharmaceutical manufacturing, and Corealis Pharma Inc., a leading early-phase Contract Development Manufacturing Organization (CDMO), have entered into a strategic alliance to provide end-to-end services for oral solid dose (OSD) development and manufacturing. The collaboration will simplify the drug development process and provide a more scalable pathway to commercialization via a single continuum.
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Marchesini Group And AST Unite To Expand Global Sterile Fill-Finish Capabilities12/9/2025
Marchesini Group, a leader in pharmaceutical packaging machinery, and AST, a U.S leader in the drug product manufacturing industry, have entered a strategic partnership that combines the expertise, technologies, and global reach of two highly respected industry leaders.
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Bora Pharmaceuticals Marks Five Years In Mississauga, Canada, Strengthening Its Commitment To Onshore And Global CDMO Excellence12/5/2025
Bora Pharmaceuticals Co., Ltd. (“Bora” or “the Company”, TWSE: 6472), a global leader in pharmaceutical manufacturing, today celebrates the five-year anniversary of its Mississauga, Ontario, Canada facility, a key hub in the company’s North American operations and a cornerstone of its expanding international CDMO network. The milestone will be celebrated onsite with employees, partners, and community stakeholders.