Orphan Drug Designation applies to approximately 50,000 Patients who predominantly suffer from severe chronic pain due to ...
This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effe ...
HRV Pharma’s innovative “virtual manufacturing” model connects FDA-approved facilities to prevent prescription shortages and ...
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
Atara Biotherapeutics stock drops on FDA rejection of EBVALLO BLA for serious post-transplant complication. FDA raises new ...
Company demonstrates commercial-scale production of its Toll-like Receptor 5 (TLR5) agonist for Acute Radiation Syndrome (ARS) and Neutropenia through wholly owned contract development manufacturing ...
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