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Results For "Food-and-Drug-Administration"

1074 News Found

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


Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer
Biotech | April 27, 2022

Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers


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


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