At the conclusion of the inspection, the US FDA issued a Form 483, listing 11 observations. Aurobindo Pharma characterised ...

Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its second FDA inspection, reaffirming the quality of its Direct-to-Patient Site for ...

WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the ...

Shilpa Pharma Lifesciences has successfully passed a U.S. FDA inspection for its Unit-2 facility in Raichur, India, with no 483 observations.

US FDA inspects Science 37’s Direct-to-Patient Site for clinical research in phase 3 asthma trial; no objectionable conditions noted: Morrisville, N.C. Thursday, April 10, 2025, ...

successfully passed U.S. Food and Drug Administration (FDA) inspections back-to-back in March — both without a single observation and with no Form 483 issued. These achievements further ...

Aurobindo Pharma's U.S. plant receives 11 observations from FDA, no impact on operations, response to be submitted.

The FDA first snubbed the combo in May 2024 due to deficiencies it identified during an inspection of a Hengrui ... 10-observation Form 483 to Hengrui’s subsidiary, Suzhou Suncadia ...

The Indian stock market closed with significant gains as global cues propelled frontline indices up by 2%. The Sensex jumped ...