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Results For "Center-for-Drug-Evaluation"

26 News Found

USFDA approves first generic of Restasis
Drug Approval | February 03, 2022

USFDA approves first generic of Restasis

Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug


USFDA expands use of Remdesivir  for Covid-19
News | January 22, 2022

USFDA expands use of Remdesivir for Covid-19

Previously, the use of the drug was limited to patients requiring hospitalization


U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir
News | December 24, 2021

U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir

The authorization provides an additional treatment option against the Covid-19 virus in the form of a pill that can be taken orally


U.S. FDA approves first treatment for drug-resistant post-transplant infection
Drug Approval | November 24, 2021

U.S. FDA approves first treatment for drug-resistant post-transplant infection

The approval is for Cytomegalovirus, a type of Herpes virus


U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism
Drug Approval | November 20, 2021

U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism

Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth


USFDA grants distinct indication for Chronic Sleep Disorder
Drug Approval | August 13, 2021

USFDA grants distinct indication for Chronic Sleep Disorder

Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder