Takeda Eohilia gets USFDA nod for people aged 11 years and older with eosinophilic esophagitis Ruchika Sharma13 Feb 2024 1:30 PM ISTOsaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and...
Aurobindo Pharma bags USFDA okay for Duchenne muscular dystrophy drug Deflazacort Ruchika Sharma13 Feb 2024 11:59 AM ISTHyderabad: Aurobindo Pharma Limited has announced that the Company has received final approval from the US Food & Drug Administration...
GSK gets USFDA Fast Track designation for Bepirovirsen in chronic hepatitis B Ruchika Sharma12 Feb 2024 3:30 PM ISTLondon: GSK plc has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an...
Dr Reddy's Labs gets USFDA EIR for Bachupally facility Ruchika Sharma12 Feb 2024 12:42 PM ISTHyderabad: Pharma major Dr Reddy's Labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United...
No new concerns raised by USFDA staff about Abbott heart device Ruchika Sharma10 Feb 2024 4:11 PM ISTThe device, already approved in more than 50 countries, is inserted through the femoral vein in the leg and is then guided and clipped on to the...
AstraZeneca-Ionis Eplontersen granted USFDA fast track designation for transthyretin-mediated amyloid cardiomyopathy Ruchika Sharma10 Feb 2024 3:30 PM ISTCarlsbad: Ionis Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ionis...
USFDA grants Breakthrough Therapy Designation for JnJ Nipocalimab for individuals at high risk for severe hemolytic disease of fetus, newborn Ruchika Sharma10 Feb 2024 12:06 PM ISTSpring House: Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation...
Zydus Lifesciences gets tentative USFDA approval for Dexamethasone Tablets USP, 1 mg Ruchika Sharma10 Feb 2024 10:00 AM ISTAhmedabad: Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) to manufacture...
Zydus Lifesciences bags USFDA nods for Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg and Dexamethasone Tablets USP, 2 mg Ruchika Sharma9 Feb 2024 11:55 AM ISTAhmedabad: Zydus Lifesciences Limited has received final approvals from the United States Food and Drug Administration (USFDA) to manufacture and...
USFDA accepts under priority review GSK application to extend indication of adjuvanted RSV vaccine Ruchika Sharma8 Feb 2024 4:30 PM ISTLondon: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted under priority review an application to extend the...
Gilead Sciences blood cancer therapy trials put on hold by USFDA Ruchika Sharma8 Feb 2024 12:30 PM ISTThe drug is an antibody treatment that blocks a type of protein, called CD47, which helps damaged cells avoid destruction by the immune system.
Piramal Pharma gets 3 USFDA observations for US facility Ruchika Sharma8 Feb 2024 11:18 AM ISTMumbai: Piramal Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded a Pre-Approval Inspection...
