Ceruvia Lifesciences, a biopharmaceutical company, announced that it has produced the world's first LSD that meets stringent "Current Good Manufacturing Practices" (CGMP) standards required by the FDA ...

On the heels of an FDA citation and export halt at Sun Pharma’s Mohali, India, manufacturing operations, the U.S. drug regulator is making clear that its demands for corrective actions are ...

cGMP production of 186RNL targeted radiotherapeutic beginning in second half of 2022 to support ongoing and future ReSPECT™ clinical trials The FDA indicated agreement with the Company’s proposed ...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Course" training has been added to ResearchAndMarkets.com's offering. This ...

SINGAPORE, December 16, 2025--(BUSINESS WIRE)--Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On ...

More than 75,000 cases of eye drops have been voluntarily recalled by a pharmaceutical testing lab after an audit by the Food & Drug Administration identified "deviations" from Current Good ...

April 19, 2012. Suntron Corp., a provider of integrated electronics manufacturing systems (EMS) and embedded computing solutions, has announced that its Phoenix facility is now cGMP compliant and FDA ...

The FDA slapped Aurobindo Pharma, an Indian drugmaker, with a warning letter for failing to adequately investigate batch failures of active pharmaceutical ingredients and not evaluating the possible ...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" training has been added to ...

ShineOn’s proprietary product, SOB100, a HLA-G targeted exosome drug delivery carrier, has passed the U.S. FDA IND review and ongoing Phase I study, making it as a first-in-class–potential HLA-G ...