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

462 News Found

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


USFDA grants direct RMAT designation for the use of ExoFlo in Covid-19 related ARDS
Biotech | April 13, 2022

USFDA grants direct RMAT designation for the use of ExoFlo in Covid-19 related ARDS

An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)


LivaNova initiates targeted commercial launch of Essenz patient monitor
Biotech | April 10, 2022

LivaNova initiates targeted commercial launch of Essenz patient monitor

An intuitive monitor featuring a patient-tailored approach is now in clinical use in select centres in U.S. and Europe


Knowledge Centre for Pharmaceutical Continuous Manufacturing
Biotech | April 08, 2022

Knowledge Centre for Pharmaceutical Continuous Manufacturing

Although PCM has advanced substantially in recent years, most of the valuable technical information resides with private companies and academic publications across multiple platforms


Proof Diagnostics seeks EUA for CRISPR-based molecular point-of-care Covid-19 test
Biotech | April 08, 2022

Proof Diagnostics seeks EUA for CRISPR-based molecular point-of-care Covid-19 test

If authorized by the USFDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for Covid-19 in as little as 18 minutes


Abott gets USFDA approval for leadless pacemaker
Drug Approval | April 05, 2022

Abott gets USFDA approval for leadless pacemaker

Aveir VR is specifically designed to be retrieved when therapy needs to evolve or the device needs to be replaced


USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19
News | April 04, 2022

USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19

If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients