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Results For "Food-and-Drug-Administration"

1021 News Found

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


Pharming gets positive review from UK MHRA for leniolisib
Biotech | April 26, 2022

Pharming gets positive review from UK MHRA for leniolisib

A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA's Early Access to Medicines Scheme


‘DREAM-ND’ and ‘DREAM-D’ Phase 3 trials of Desidustat published in American Journal of Nephrology
Biotech | April 25, 2022

‘DREAM-ND’ and ‘DREAM-D’ Phase 3 trials of Desidustat published in American Journal of Nephrology

Desidustat is currently approved only in India as OxemiaTM for patients with CKD induced anemia


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


Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets
Drug Approval | April 18, 2022

Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India


Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg
Drug Approval | April 15, 2022

Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg

The product will be manufactured at Lupin’s facility in Goa, India