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 ...

The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.

WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that two of its manufacturing facilities in Wuxi –Drug Product Facility 5 ...

Atara Biotherapeutics stock drops on FDA rejection of EBVALLO BLA for serious post-transplant complication. FDA raises new ...

SAN DIEGO, CA / ACCESS Newswire / January 7, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or ...

Company demonstrates commercial-scale production of its Toll-like Receptor 5 (TLR5) agonist for Acute Radiation Syndrome (ARS ...

MSMEs need handholding to implement online submission of CDSCO mandated WHO-GMP CoPP: BDMAI: Shardul Nautiyal, Mumbai Monday, January 12, 2026, 08:00 Hrs [IST] Pharma MSMEs need a ...

US FDA accepts Camurus’ resubmission of NDA for Oclaiz for treatment of acromegaly: Lund, Sweden Monday, January 12, 2026, 15:00 Hrs [IST] Camurus, an international, science-led ...

Two men have since been charged following the raid. Anthony Mills, 41, of Glenmore Drive, Failsworth, has been charged with ...

MedPharm’s topical drug product manufacturing facility in Durham has successfully completed an FDA inspection for commercial ...

GALVESTON, TX / ACCESS Newswire / January 12, 2026 / Callan JMB Inc. (NASDAQ:CJMB), a premier provider of vertically ...

SAN DIEGO, CA / ACCESS Newswire / January 7, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on rebalancing in ...