Transform Downstream Processing with an Integrated Solution
The MOTIV Inline Buffer Formulation System paired with FlexiPro Chrom creates a synchronized, closed-loop buffer production workflow control…
Curated regulatory guidance, clinical analyses, and market reports. AI-summarized, editor-reviewed, instantly downloadable.
Research Pulse
Aggregated from live regulatory feedsNovaPharmaNews hosts 68 curated pharmaceutical whitepapers and industry reports from 8 publishers — FDA and EMA regulatory guidance, clinical analyses, manufacturing intelligence, and market research. 3 featured reports are editor-picked this week. Each landing page includes key takeaways, optional PDF download, and links to related drugs, companies, and pipeline data.
Methodology & data sources Publications & analysis Editorial policy
Transform Downstream Processing with an Integrated Solution
The MOTIV Inline Buffer Formulation System paired with FlexiPro Chrom creates a synchronized, closed-loop buffer production workflow control…
Examining the Validity of External Controls Relative to Randomized Controls
EMA case studies in non-small cell lung cancer (NSCLC) and relapsed/refractory multiple myeloma (RRMM) showed external controls can replicat…
FDA Draft Guidance on AI in Drug Development Explained
The FDA released draft guidance "Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making" on January 6, …
507 DTx devices approved across four major markets as of December 2024: China (235), US (192), Germany (55), and Belgium (25) [Nature]
Radiopharmaceuticals - EU-IN Horizon Scanning Report
The EU has approved 20 radiopharmaceuticals. Five treat cancer. Fifteen aid diagnosis. Four work as theranostics for personalised care. See …
Cytological Specimens in the Molecular Era of Metastatic Melanoma
Ultrasound-guided FNAC detects 65% of sentinel node metastases with 99% specificity, providing a less invasive alternative to surgical biops…
ASHP Policy Positions 1982-2026
A comprehensive catalog of professional policy positions by ASHP, advocating for pharmacy practice and public health.
This whitepaper outlines the Medicare Advantage capitation rates and payment policies for 2027, emphasizing stakeholder feedback and risk ad…
This review discusses the 2024 revision of EU GMP Annex 1, focusing on contamination control and quality risk management in sterile manufact…
Scientific Standards for 23andMe's Health and Trait Reports
This white paper outlines the scientific standards for 23andMe's genetic health and trait reports, emphasizing validity and evidence-based p…
AESGP Position on Commission Proposal for Simplification of MDR
This position paper outlines AESGP's recommendations on simplifying medical device regulations in Europe.
This whitepaper discusses strategies for enhancing post-approval compliance in pharmaceuticals through integrated governance and AI.
Strengthening the FDA's Accelerated Approval Pathway: Progress and Unfinished Business
This whitepaper reviews the FDA's Accelerated Approval pathway, highlighting its evolution, challenges, and proposed reforms.
Overview of Comments Received on ICH Q3E Guideline
This document summarizes comments on the ICH Q3E Guideline regarding extractables and leachables, focusing on regulatory and safety consider…
Entity directories linked from research reports and market briefs.
Our research library curates FDA, EMA, and industry publisher PDFs — regulatory guidance, clinical analyses, manufacturing reports, and market intelligence. Each report includes an AI-summarized landing page with key takeaways and a gated PDF download.
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Report pages link to related intelligence — company profiles, drug INN pages, clinical trials, pipeline programs, and topic hubs. Use the intelligence spokes on each page to explore the entity graph behind the research.
New reports are ingested daily from leading publishers and regulatory sources. Featured picks highlight high-impact FDA, EMA, and industry research each week.