FDA announces CMC review pilot for drugs with expedited development The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development ...

CMC hurdles stall Korea drug approvals as KDDF and KCMC mobilize support National push aims to build end‑to‑end CMC capacity ...

The first generation of strategic sourcing relationships in clinical research is coming up for renewal, and the CRO industry is watching carefully to see how they renew. Strategic sourcing ...

Antibody-drug conjugates (ADCs) are transforming oncology with their ability to deliver potent cytotoxic agents directly to tumor cells, combining the targeting precision of monoclonal antibodies with ...

Dublin, March 17, 2025 (GLOBE NEWSWIRE) -- The "A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products Training Course" has been added to ResearchAndMarkets.com's ...

Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...

Industry experts shared their insights and expertise on overcoming the most pressing Chemistry, Manufacturing, and Controls (CMC) challenges at LSX Biopharm America on September 11. This article ...

In this free webinar, learn how to reduce delays and improve efficiency in Chemistry, Manufacturing and Controls (CMC) development. The featured speaker will discuss and understand common obstacles, ...

The first generation of strategic sourcing relationships in clinical research is coming up for renewal, and the CRO industry is watching carefully to see how they renew. Strategic sourcing ...