Find out how NAMs are influencing safety assessments and decision-making in the pharmaceutical industry ahead of 2026.
Regulatory planning and development assessment encompass a coordinated suite of methodologies aimed at evaluating the impact, efficiency and equity of planning policies and regulatory interventions.
Early-stage regulatory strategy is becoming a powerful driver of speed, risk reduction, and commercial value in drug ...
Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time Receives confirmation from FDA that Agency’s review of Anaphylm NDA ...
Effective and meaningful public engagement are “foundational principles of Federal regulatory development” and the Biden Administration has sought to remove barriers to public participation in the ...
In 2023, the FDA rejected a small pharmaceutical company's new drug application (NDA) with a Refusal-to-File (RTF) decision. This letter provided information on a range of issues within the submission ...
Let's start with the exciting news about tokenization-related activities. The SFC has issued two important circulars to address the risks and regulatory requirements in this area. The first one ...
WARREN, N.J., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to ...
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