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FDA Requires Drug Establishment Registration

November 4, 2026
Establishments engaged in manufacturing, repacking, relabeling, or salvaging drugs for U.S. distribution are required to register with the FDA, with certain exemptions. This requirement underscores the regulatory framework that governs drug manufacturing and distribution in the United States. Manufacturers and suppliers must ensure compliance with these registration requirements to avoid potential penalties and ensure uninterrupted…
scientist conducting clinical trial research

Recursion Plans H2 2027 Trial for REC-4881 After Positive FAP Data

November 4, 2026
Recursion expects to launch its first registrational trial in the second half of 2027 for its lead candidate REC-4881, following positive mid-stage clinical data for the oral therapy targeting familial adenomatous polyposis (FAP). The Phase Ib/II TUPELO trial data indicated that most patients treated with REC-4881 experienced reductions in both the number of larger, higher-risk…
Scientist working in a laboratory

FDA Calls for Stronger Potency Upkeep in CGT Manufacturing

November 4, 2026
The FDA’s CBER director emphasized the need for stronger potency maintenance in cell and gene therapy (CGT) manufacturing. This call for enhanced oversight aims to ensure that patients can trust that the products they receive will perform as intended. The FDA’s focus on potency is critical as it directly impacts the efficacy and safety of…
Person holding their head in pain

AbbVie Inks $757M Migraine-Focused Deal with Brise Pharmaceuticals

November 4, 2026
AbbVie and Brise Pharmaceuticals have shared details on a migraine-focused deal valued at $757 million. This announcement comes two years after the two companies originally forged the partnership. The collaboration aims to advance the development of treatments for migraine, a condition that affects millions worldwide. This deal may enhance AbbVie’s portfolio in the competitive migraine…

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