USFDA issues 7 observations for Aurobindo Pharma arm Telagana injectable facility Ruchika Sharma1 March 2024 2:00 PM ISTTelangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection with 7...
Biocon Biologics Biocon Campus (Site 1) facility gets 4 USFDA observations Ruchika Sharma1 March 2024 12:01 PM ISTBangalore: Biocon has recently announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483s with 4 observations at...
Bayer gets USFDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer harboring HER2 activating mutations Ruchika Sharma29 Feb 2024 1:30 PM ISTBAY 2927088 was derived from Bayer's long-standing strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.
Alkem Labs gets USFDA EIR for Mandva facility Ruchika Sharma29 Feb 2024 11:54 AM ISTMumbai: Alkem Labs has announced that US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the...
Expanded Indication for Gilead Biktarvy for HIV with suppressed viral loads, pre-existing resistance gets USFDA okay Ruchika Sharma27 Feb 2024 12:30 PM ISTFoster City: Gilead Sciences, Inc. has announced the U.S. Food and Drug Administration (FDA) has approved a new, expanded indication for Biktarvy...
Piramal Pharma gets 2 USFDA observations for Lexington facility Ruchika Sharma26 Feb 2024 4:03 PM ISTMumbai: Piramal Pharma has announced that the US Food and Drug Administration (US FDA) has concluded a Pre-Approval Inspection (PAI)...
Orchid Pharma bags USFDA nod for Enmetazobactam Ruchika Sharma24 Feb 2024 1:30 PM ISTThis New Drug Approval allows the use of Exblifep (Cefepime and Enmetazobactam) as an injection for the treatment of patients 18 years and older with...
USFDA completes inspections at Suven Pharma facilities with no form 483 Ruchika Sharma24 Feb 2024 11:45 AM ISTHyderabad: Suven Pharma has announced that the US Food & Drug Administration (US FDA) has completed the inspections at the Company's...
Dupixent application accepted for priority review by USFDA for COPD with type 2 inflammation Ruchika Sharma23 Feb 2024 4:30 PM ISTParis: Sanofi has announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License...
USFDA accepts for priority review Bristol Myers Squibb application for Krazati, cetuximab combo for colorectal cancer Ruchika Sharma22 Feb 2024 1:30 PM ISTNew York: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental...
Merck application for Keytruda plus chemotherapy for Primary Advanced or Recurrent Endometrial Carcinoma accepted by USFDA for priority review Ruchika Sharma22 Feb 2024 12:30 PM ISTRahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA) has accepted for...
JnJ gets USFDA nod for Bi-weekly dose of blood cancer therapy Tecvayli Ruchika Sharma21 Feb 2024 11:39 AM ISTUnited States: The U.S. Food and Drug Administration has approved a bi-weekly dose of Johnson & Johnson's blood cancer therapy Tecvayli, the...
