Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...
The Phase 1/2 trial is a first-in-human, open-label, multi-national study designed to evaluate the safety, tolerability, and efficacy of TSRA-196 in adults with AATD. Trial participants will receive a ...
The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...
Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for ...
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
The US Food and Drug Administration (FDA) has cleared GenEditBio Limited’s Investigational New Drug (IND) application to ...
Moving Biotech receives US FDA’s IND clearance for 4P004; strengthens its position as a leading innovator in disease-modifying osteoarthritis therapeutics: Lille, France Saturd ...
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