Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
“ADDRI’s leadership in asbestos-related disease makes Australia a compelling setting for a TT-4 investigator-initiated trial,” said Peter Molloy, Chief Executive Officer, Cyncado Therapeutics. “We are ...
AI drives decision inputs: In 2025, both big pharma and small pharma use advanced predictive modeling, digital twins, and AI-powered analytics throughout R&D and regulatory processes. This reduces ...
The OCTDI under the Office of the Vice President for Health Sciences serves as a hub interconnecting interdisciplinary clinical trial research collaborations among UB investigators and our regional ...
The field of rare cancer research is rapidly transforming, marked by significant progress in clinical trials and treatment strategies. Rare cancers, as defined by the National Cancer Institute, occur ...
The Company’s presentation showcased promising early data on the viability and potency of cells from its proprietary Master Cell Bank (“MCB”). The MCB represents a valuable and key strategic asset in ...
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development ...
China, already gaining speed in biotechnology, is looking to further accelerate novel drug development by reducing the time regulators take to review clinical trials. In a draft policy posted (Chinese ...
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FDA looks to simplify biosimilar development with new draft guidance
The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...
On October 29, 2025, the FDA released a new draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference ...
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