FEATURE ARTICLES
FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.
- Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative
- Making Mental Health Drugs: Promising Therapies And Manufacturing Challenges
- The Stepwise Path Lilly Mapped From Paper To Digital Logbooks
- A 5-Step Foundation For Early CQV Involvement
- Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline
- Overcoming 3 Key Challenges Of Working With CDMOs For Radiopharmaceuticals
- Selecting The Right eQMS To Maximize Quality Maturity
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1396008671 RNA, DNA sequencing]( "Epigenetics Application Guide: RNA Modifications")
Epigenetics Application Guide: RNA ModificationsLearn about the rapidly evolving field of RNA modifications, including innovative techniques like miCLIP and RIP for mapping chemical modifications and understanding RNA’s role in cellular processes.
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Process Development For Lyophilized Products10/16/2024
Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.
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Exploring Agentic AI In GMP Operations8/12/2025
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.
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The Impact Of Artificial Intelligence On CQV7/23/2025
AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.
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Optimizing Charge And N-glycan Profiles For CHO-Derived Fusion Proteins9/24/2025
Discover how structured design-of-experiment approaches can optimize charge variants and glycosylation to enhance biologics quality and therapeutic performance.
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Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells6/28/2024
Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Product Recovery Study For Fill Finish Applications
- Contamination In The Shadows: Risks Lurking From Environmental Issues
- Detection And Quantification Of Amorphous Content In Materials
- Successful Method Migration Of The USP Quetiapine Fumarate Impurities Method
- Practical Considerations For Aseptic Gowning In Contamination Control Strategies (CCS)
NEWSLETTER ARCHIVE
- 05.05.26 -- March 2026 — CDMO Opportunities And Threats Report
- 05.02.26 -- Quality Assurance Product Showcase
- 05.01.26 -- ISPE Announces 2026 FOYA Winners
- 04.30.26 -- The Hidden Operational Cost Contained In Every Small Molecule Portfolio
- 04.30.26 -- STREAM Edition: Selecting Equipment And Technology
INDUSTRY NEWS
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![rating service, satisfaction-GettyImages-2221603596]( "ISPE Announces 2026 FOYA Winners")
ISPE Announces 2026 FOYA WinnersThese awards recognize pharmaceutical and biopharmaceutical manufacturing projects that demonstrate excellence across innovation, operations, supply chain, Pharma 4.0, and social impact.
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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.
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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Compact & Powerful Double Planetary Mixer For Lab And Pilot-Scaling4/30/2026
ROSS has delivered an ergonomic and powerful Double Planetary Mixer Model DPM-10 engineered for high-viscosity and specialty material processing in laboratory and pilot-scale operations.
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AES Cleanroom Technology appoints John Groth As Chief Revenue Officer4/27/2026
AES Cleanroom Technology, a leading provider of modular cleanroom design, manufacturing, and construction solutions for the life sciences and biopharmaceutical industries, has appointed John Groth as Chief Revenue Officer as demand grows for flexible, high-performance manufacturing environments across pharma and biotech.
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Navigating Change: Key Industry Insights At PHARMAP 20264/27/2026
The Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) 2026 brought together senior industry leaders on 20-21 April in Amsterdam for two days of focused discussion on the forces reshaping pharmaceutical manufacturing. Held in partnership with Astellas Pharma Europe, GSK, ESTEVE, Laboratoires Théa and Recipharm, the Congress covered global manufacturing strategies, supply chain resilience, packaging innovation and many other topics.
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AbbVie Announces $1.4 Billion North Carolina Campus To Expand U.S. Pharmaceutical Manufacturing Capacity4/27/2026
AbbVie today announced a $1.4 billion investment to build a 185-acre pharmaceutical manufacturing campus in Durham, North Carolina. The state-of-the-art campus will integrate advanced manufacturing and laboratory technologies with artificial intelligence (AI) to support the production of AbbVie's immunology, neuroscience and oncology medicines.
