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
-
Three Steps To Digital Transformation In Life Sciences Manufacturing
Explore trends that are transforming the industry, some common speedbumps on the road to innovation, and how a new platform offers unprecedented process transparency and continuous improvement.
-
Unlocking The Potential Of Biocatalysis1/22/2026
Biocatalysis delivers cleaner, more selective pharma processes while cutting energy use and waste. Engineered enzymes broaden their reach, enabling faster development and greater sustainability.
-
Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes4/8/2025
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
-
The Future Of Cleaning Validation7/23/2025
Explore evolving cleaning validation strategies in life sciences, from regulatory foundations to digital innovations, and discover how agile, risk-based approaches can enhance compliance and efficiency.
-
The Complete Guide To Immunohistochemistry9/24/2024
Immunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
-
Safety, Containment, And Analysis Of Highly Potent Compounds5/16/2024
Explore a comprehensive overview of the challenges, requirements, and best practices for safely working with highly potent compounds in drug development and manufacturing.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 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
- 04.07.26 -- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
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
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
-
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.
-
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
-
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.
-
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.
-
Samsung Biologics Completes Acquisition Of GSK's Manufacturing Facility In Rockville, Maryland3/31/2026
Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), today announced the completion of its acquisition of a manufacturing facility in Rockville, Maryland from GSK, establishing the company's first manufacturing presence in the United States.