“FDA has not yet developed action plans to fully address travel, workload, and work-life balance because potential solutions ...

The FDA conducted an inspection at the manufacturing facility in Virgonagar from Nov. 7 to Nov. 13, according to an exchange ...

Mumbai: Cipla has announced that the United States Food and Drugs Administration (USFDA) has concluded an inspection at the ...

The U.S. Food and Drug Administration has lifted a clinical hold on three cell therapies being developed by CARsgen ...

Both firms received a Form FDA 483a, detailing their serious compliance lapses ... for Enoki and King Oyster Mushrooms imported from multiple suppliers. A recent FDA inspection triggered by findings ...

Vijayawada: The Andhra Sugars Limited has undergone US FDA inspection at their aspirin manufacturing facility at ...

Pharma player Granules India Limited on Friday said it has received an Establishment Inspection Report (EIR) from the US Food ...

Good morning and welcome to ImmuCell Corporation Reports Third Quarter September 30, 2024, Unaudited Financial Results Conference Call. All participants will be in listen-only mode. After today’s ...

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 ...

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 ...

Hyderabad: Granules India Limited, a pharmaceutical manufacturing company, has announced that it has received an ...

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 ...