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Results For "Food-and-Drug-Administration"

1074 News Found

Zydus receives USFDA approval to market Silodosin and Pregabalin capsules
Drug Approval | December 12, 2022

Zydus receives USFDA approval to market Silodosin and Pregabalin capsules

Silodosin capsules treat signs and symptoms of an enlarged prostate gland


Roche presents new data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022
Diagnostic Center | December 12, 2022

Roche presents new data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022

Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes


BASF Pharma Solutions excipient accepted into FDA Pilot Program
Drug Approval | December 06, 2022

BASF Pharma Solutions excipient accepted into FDA Pilot Program

Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients


Zydus receives final approval from USFDA for Estradiol Transdermal System
Drug Approval | December 05, 2022

Zydus receives final approval from USFDA for Estradiol Transdermal System

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad


Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate
News | December 05, 2022

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


Zydus receives final approval from USFDA for Topiramate Extended-Release capsules
Drug Approval | December 02, 2022

Zydus receives final approval from USFDA for Topiramate Extended-Release capsules

Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)


Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)
Drug Approval | November 30, 2022

Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)

Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.


Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection
Drug Approval | November 29, 2022

Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection

The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India


Briefs: IOL Chemicals and Cipla
News | November 27, 2022

Briefs: IOL Chemicals and Cipla

Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".