The FDA conducted an inspection at the manufacturing facility in Virgonagar from Nov. 7 to Nov. 13, according to an exchange ...
A key reason positions haven't been filled is that they require travel that ranges from 25% to 75% of the time.
The U.S. Food and Drug Administration has lifted a clinical hold on three cell therapies being developed by CARsgen ...
The investigation focuses on Humacyte’s statements about the FDA’s inspections and the company ... 2024 sent her a letter on Form 483 which was not published until October 17, 2024 that ...
Vijayawada: The Andhra Sugars Limited has undergone US FDA inspection at their aspirin manufacturing facility at ...
Novo Nordisk landed in hot water with the FDA following an inspection at one of the drugmaker’s key semaglutide and insulin manufacturing plants this past spring. | The FDA issued a ...
October's food recalls were initiated for reasons ranging from undeclared allergens to potential contamination with dangerous ...
Pharma player Granules India Limited on Friday said it has received an Establishment Inspection Report (EIR) from the US Food ...
From April 8-12, the U.S. FDA had conducted a comprehensive pre-approval inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations, Granules said. “The successful completion of ...
In July 2024, Checkpoint announced that the FDA accepted for review the resubmission of its BLA for cosibelimab as a complete response to the complete response letter (“CRL”) issued in December 2023 ...
DURHAM, N.C., Nov. 08, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at ...
Hagens Berman urges investors in Humacyte, Inc. (NASDAQ: HUMA) who suffered substantial losses to submit your losses now .