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

628 News Found

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years
Biotech | April 29, 2022

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years

Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children


Camzyos is the first and only USFDA-approved cardiac myosin inhibitor
Biotech | April 29, 2022

Camzyos is the first and only USFDA-approved cardiac myosin inhibitor

Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo


Kapruvia approved by European Commission for hemodialysis patients
Drug Approval | April 28, 2022

Kapruvia approved by European Commission for hemodialysis patients

First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients


Zymo invests in Star Array to develop superfast PCR platform
Biotech | April 27, 2022

Zymo invests in Star Array to develop superfast PCR platform

Star Array's focus has been on the development of an automated (cassette-based) nucleic acid purification system coupled with its superfast nucleic acid amplification technology


USFDA approves first Covid-19 treatment for young children
Drug Approval | April 26, 2022

USFDA approves first Covid-19 treatment for young children

This action makes Veklury the first approved Covid-19 treatment for children less than 12 years of age


Dr. Reddy's launch Posaconazole delayed-release tablets in the US
Drug Approval | April 21, 2022

Dr. Reddy's launch Posaconazole delayed-release tablets in the US

The tablets are available in 100 mg strength in bottle count sizes of 60


ZEISS announces USFDA clearance of the Quatera 700
Digitisation | April 21, 2022

ZEISS announces USFDA clearance of the Quatera 700

The latest technology from ZEISS empowers surgeons with one complete, digitally integrated cataract workflow for efficiency without compromise


MicroGEM granted EUA for Covid-19 PCR Saliva test
Biotech | April 20, 2022

MicroGEM granted EUA for Covid-19 PCR Saliva test

The MicroGEM Saliva test is the first point of care PCR saliva test for Covid-19 delivering results in minutes


SonoScape receives USFDA 510(k) clearance for HD-550 Endoscopy system
Drug Approval | April 18, 2022

SonoScape receives USFDA 510(k) clearance for HD-550 Endoscopy system

The HD-550 endoscopy system has been available outside of the USA since 2019


Amneal achieves second U.S. biosimilars approval with Alymsys
Drug Approval | April 18, 2022

Amneal achieves second U.S. biosimilars approval with Alymsys

Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022