US FDA calls for USFDA boxed warning changes on CAR-T cancer therapies Kajal Rajput19 April 2024 1:32 PM ISTLondon: The U.S. Food and Drug Administration said on Thursday cancer therapies that use CAR-T technology will require changes to the so-called...
USFDA successfully concludes inspection at Piramal Pharma USA facility Ruchika Sharma18 April 2024 5:36 PM ISTMumbai: Piramal Pharma Limited has informed through a recent BSE filing that the US Food and Drug ADministration (US FDA) has issued an...
Marksans Pharma gets 5 inspectional observations from USFDA for Goa facility Ruchika Sharma18 April 2024 12:14 PM ISTMumbai: Marksans Pharma has received 5 inspectional observations in Form 483 from the US Food and Drug Administration (USFDA) at...
FDA fast tracks enibarcimab for the treatment of septic shock Dr. Kamal Kant Kohli18 April 2024 7:45 AM IST It is believed that modulation of ADM pathway may improve outcomes in patients with septic shock. The Food and Drug Administration has granted...
USFDA approves Selarsdi injection for subcutaneous use to treat severe plaque psoriasis, active psoriatic arthritis: Alvotech, Teva Ruchika Sharma17 April 2024 4:18 PM ISTReykjavik: Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., have announced that the U.S. Food and Drug...
USFDA accepts for review GSK 5-in-1 meningococcal ABCWY vaccine candidate Ruchika Sharma17 April 2024 10:00 AM ISTLondon: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for...
Glenmark Pharma recalls 6528 bottles of BP drug in US Ruchika Sharma15 April 2024 1:36 PM ISTNew Delhi: Glenmark Pharmaceuticals is recalling 6,528 bottles of a medication prescribed for the treatment of high blood pressure in the...
Granules India gets Zero 483's from USFDA for Unit V facility in AP Ruchika Sharma13 April 2024 12:08 PM ISTTelangana: Granules India has informed in a BSE filing that the Company's Unit V facility located at Anakapally, Visakhapatnam, Andhra ...
USFDA concludes inspection of Lupin Dabhasa facility with no observations Ruchika Sharma13 April 2024 11:48 AM ISTMumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has completed a GMP...
Sun Pharma receives OAI status from USFDA for Dadra facility Ruchika Sharma12 April 2024 11:42 AM ISTMumbai: Sun Pharma has informed in a BSE filing that the US Food and Drug Administration (USFDA) has determined the inspection classification...
FDA clears non invasive device for treatment of anxiety Dr. Kamal Kant Kohli11 April 2024 10:00 PM ISTThe US Food and Drug Administration has cleared Modius Stress to treat generalized anxiety disorder.Made by Neurovalens is a non-invasive electrical...
Roche gets USFDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis Ruchika Sharma11 April 2024 5:47 PM ISTBasel: Roche has announced that its Elecsys pTau217 assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration...
