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

461 News Found

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


Amneal gets approval for Difluprednate ophthalmic emulsion
Drug Approval | November 22, 2021

Amneal gets approval for Difluprednate ophthalmic emulsion

The company is moving towards complex and more differentiated products


FDA grants Theradaptive Breakthrough Medical Device designation
Medical Device | November 22, 2021

FDA grants Theradaptive Breakthrough Medical Device designation

Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications


U.S. FDA allows Pfizer and Moderna booster doses for all
News | November 20, 2021

U.S. FDA allows Pfizer and Moderna booster doses for all

This is a shot in the arm for the vaccine manufacturers


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


Roche launches cobas 5800, a new molecular diagnostics system
Digitisation | November 18, 2021

Roche launches cobas 5800, a new molecular diagnostics system

The system is a compact new addition to the Roche Molecular portfolio, providing efficiency, simplicity and timely results to laboratories of all sizes.


Pfizer seeks EUA from U.S. FDA for Covid-19 drug
Biotech | November 17, 2021

Pfizer seeks EUA from U.S. FDA for Covid-19 drug

If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2


U.S FDA authorises EaseVRx, immersive virtual reality for pain relief
Drug Approval | November 17, 2021

U.S FDA authorises EaseVRx, immersive virtual reality for pain relief

EaseVRx employs the principles of cognitive behavioural therapy and other behavioural therapy techniques for the reduction of pain and pain interference


Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay
Biotech | November 12, 2021

Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay

The company expects to begin shipping this product before the end of its fiscal first quarter, ending December 31, 2021


Sun Pharma to introduce molnupiravir in India
Drug Approval | November 12, 2021

Sun Pharma to introduce molnupiravir in India

The Drug Controller General of India (DCGI), is reviewing clinical data of molnupiravir for the treatment of Covid-19 in adults in India