In this podcast episode, we discuss the journey of novel modalities in rare disease treatment to patients, particularly advancements in oncology and the increasing role of patients' families in ...
Unlock the potential of high-purity methylcellulose in biotech. Join our upcoming webinar to explore how METHONOVA™ enhances ...
FDA will convene a one-day, in-person and virtual public workshop, “Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine ,” on Tuesday, Dec. 16, 2025 (1). The workshop is ...
Gain leadership and innovation insights from CEO of the Year finalist at 2025 CPHI Pharma Awards, Mahler Hanns-Christian, who ...
The CNPV pilot program significantly reduces review times, but may challenge safety standards and resource allocation.
The CNPV pilot program reduces review times from 10-12 months to 1-2 months, benefiting generics and biosimilars. Companies must align market access, manufacturing, and post-approval readiness with ...
Artificial intelligence (AI) and machine learning (ML) tools offer an ultra-material-sparing approach to accelerate ...
AI and ML predict solubilization technologies, optimizing drug-excipient interactions and reducing trial-and-error in formulation development. Digital twins, trained ...
In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how CDMOs can best handle ...
The CNPV program accelerates drug approval, requiring a shift to parallel execution and pre-submission readiness. Robust manufacturing and quality systems are critical, as compliance gaps cannot be ...
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