FEATURE ARTICLES
Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
- 4 Facility Considerations for API Manufacturing
- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
- Generative AI Can Write The Code, But Who Builds In The Quality?
- February 2026 — CDMO Opportunities And Threats Report
- FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes
- Clearing The Fog On New First Air Visualization Expectations
- FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1259094551 Digital quality]( "Combining Digital Platforms And QbD Principles")
Combining Digital Platforms And QbD PrinciplesHow can data and digitalization further improve pharmaceutical development and the continuous, quick, and efficient delivery of products?
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Establishing Commercial Manufacturing Services For ADCs6/3/2024
Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.
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Optimal Microbial Sampling Criteria6/24/2025
Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
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A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
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Redefining OSD Development Through Foresight And Innovation2/12/2026
From early formulation challenges to scale-up and commercial readiness, proactive planning and integrated capabilities help teams anticipate risks, accelerate decision-making, and maintain momentum across development.
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Mastering Ethylene Oxide Sterilization: Your Comprehensive Field Guide9/4/2025
Whether you're refining existing protocols or developing new ones, this guide serves as a valuable resource for ensuring safe, effective, and compliant sterilization outcomes.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 04.11.26 -- Pharmaceutical Online Best Of March
- 04.09.26 -- Clearing The Fog On New First Air Visualization Expectations
- 04.09.26 -- STREAM Edition: API Facility Considerations
- 04.08.26 -- Advancing Next-Generation Biologics: From Cell Line Innovation To Complex Modalities
- 04.07.26 -- Aseptic Insights & Automation
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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Symbiosis Expands Commercial Capabilities With Addition Of New Stability Chamber4/1/2026
Symbiosis Pharmaceutical Services (Symbiosis), a Contract Development and Manufacturing Organisation (CDMO) specialising in the sterile GMP manufacturer of injectable drug products, has expanded its Quality Control (QC) laboratory with the installation of a new 30°C stability chamber.
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Eli Lilly's Foundayo™ Approved By FDA, Introducing A New Era Of Needle-Free GLP-1 Therapy4/1/2026
Foundayo, Lilly's second FDA-approved obesity medicine, will be available via LillyDirect® with free home delivery, starting at $25 per month with commercial coverage and $149 for self-pay
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ROIS CDMO Closes On The Acquisition Of US Injectable Manufacturing Facility4/1/2026
ROIS, the CDMO arm of ROVI and a leader in injectable manufacturing, today announces closing the acquisition of a state-of-the-art injectable drug product manufacturing and packaging site in Phoenix, Arizona (USA) from Bristol Myers Squibb.
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IMA Acquires Isolator Equipment Provider Prosys Sampling Systems Limited4/1/2026
The IMA Group strengthens its presence in aseptic and containment isolator technology. IMA has recently signed with ProSys Sampling Systems Limited an agreement that provides for the purchase of a majority of the company’s shares. Established in 1997, ProSys is a leading provider of Isolator and Sampling equipment to the global bio-pharmaceutical market.
