Roche receives USFDA Breakthrough Device Designation for Multiple Sclerosis test Elecsys NfL Ruchika Sharma10 Nov 2023 12:30 PM ISTElecsys NfL has the potential to help laboratories to scale MS testing on widely available, fully automated and standardised Roche cobas instruments...
FIRST: Takeda gets USFDA nod for Adzybm for rare inherited Blood Clotting Disorder Ruchika Sharma10 Nov 2023 11:39 AM ISTOsaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved ADZYNMA (ADAMTS13, recombinant-krhn) for the...
USFDA issues EIR for Piramal Pharma Bethlehem facility Ruchika Sharma9 Nov 2023 3:24 PM ISTMumbai: Piramal Pharma has announced that the United States Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR)...
Eli Lilly bags USFDA nod for Zepbound injection for weight loss Ruchika Sharma9 Nov 2023 1:30 PM ISTZepbound should be used with a reduced-calorie diet and increased physical activity.
Gland Pharma Visakhapatnam facility gets USFDA EIR Ruchika Sharma9 Nov 2023 12:30 PM ISTTelangana: Gland Pharma has recently announced that the Company has received Establishment Inspection Report (EIR) from the United States Food and...
Lupin gets tentative USFDA nod for Canagliflozin, Metformin Hydrochloride ER tablets Ruchika Sharma8 Nov 2023 10:52 AM ISTCanagliflozin and Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in...
Zydus Lifesciences wins USFDA nod for diabetes drug Zituvimet Ruchika Sharma6 Nov 2023 11:34 AM ISTThe approval of ZITUVIMET is based on research, development, regulatory, and manufacturing work performed by Zydus teams.
Abbott receives USFDA nod for HPV screening solution Ruchika Sharma4 Nov 2023 3:39 PM ISTAbbott Park, Ill.: Abbott has received U.S. Food and Drug Administration (FDA) approval for its molecular human papillomavirus or HPV screening...
Marksans Pharma arm receives EIR from USFDA Ruchika Sharma4 Nov 2023 12:30 PM ISTMumbai: Marksans Pharma Limited has announced that its wholly owned subsidiary Time-Cap Laboratories, Inc. has received Establishment Inspection...
USFDA Officials propose for "US FDA - Telangana DCA Regulatory Forum" for future strategic collaboration Ruchika Sharma3 Nov 2023 2:49 PM ISTThis regulatory forum discusses elements of Observed Inspection for future participation of Inspectors of DCA, Telangana as an observer in the US FDA...
Lupin unveils Diazepam Rectal Gel in US Ruchika Sharma3 Nov 2023 11:34 AM ISTMumbai: Global pharma major Lupin Limited has announced the launch of Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System, after its wholly...
Marksans Pharma Goa facility undergoes successful inspection from German Health Authorities Ruchika Sharma2 Nov 2023 5:30 PM ISTMumbai: Marksans Pharma Limited has recently announced that the Company's newly acquired Goa manufacturing facility has successfully undergone...
