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Results For "U.S.-Food-and-Drug-Administration"

594 News Found

USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana
Drug Approval | September 29, 2023

USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana

The delegation's visit covered a wide range of topics


Insmed announces positive results from Phase III arise study of ARIKAYCE
News | September 06, 2023

Insmed announces positive results from Phase III arise study of ARIKAYCE

Patients Treated with ARIKAYCE plus macrolide-based background regimen had meaningfully larger improvements in QOL-B respiratory score


USFDA delegation visits Amneal Pharmaceutical facility in Matoda
News | September 02, 2023

USFDA delegation visits Amneal Pharmaceutical facility in Matoda

Amneal’s site in Matoda is one of the company’s 12 pharmaceutical manufacturing facilities


USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes
Drug Approval | September 01, 2023

USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes

Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia


Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules
Drug Approval | August 22, 2023

Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules

Oteseconazole Capsules were found to be safe and more effective than fluconazole


Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma
Drug Approval | August 16, 2023

Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma

ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity


Tulasi Healthcare Introduces dTMS Therapy service for Treatment-Resistant Depression
Healthcare | August 16, 2023

Tulasi Healthcare Introduces dTMS Therapy service for Treatment-Resistant Depression

Deep Transcranial Magnetic Stimulation (dTMS) is a non-invasive brain stimulation technique approved by regulatory authorities, including the USFDA


Boehringer Ingelheim receives FDA approval for Senvelgo to treat diabetes in cat
Drug Approval | August 16, 2023

Boehringer Ingelheim receives FDA approval for Senvelgo to treat diabetes in cat

Senvelgo is the first liquid once-daily, orally administered prescription medication to improve glycemic control in cats with diabetes mellitus


USFDA approves Merck’s ERVEBO for use in children 12 months of age and older
Drug Approval | August 05, 2023

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease