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Results For "FDA"

1718 News Found

Aleor Dermaceuticals receives USFDA approval for Clobestasol
Drug Approval | April 25, 2022

Aleor Dermaceuticals receives USFDA approval for Clobestasol

Clobetasol Propionate Foam, 0.05% has an estimated market size of US $ IO million for twelve months ending Dec 2021 according to IQVIA


USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial
Biotech | April 22, 2022

USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial

The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic


Qvella FAST System and FAST-PBC get CE marked and USFDA listed
Biotech | April 22, 2022

Qvella FAST System and FAST-PBC get CE marked and USFDA listed

With the commercialization of Qvella technology for Positive Blood Culture (PBC) processing, healthcare facilities can now get results up to 24 hours faster than current methods


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


Alembic Pharmaceuticals receives USFDA tentative approval for heart failure drug
Drug Approval | April 20, 2022

Alembic Pharmaceuticals receives USFDA tentative approval for heart failure drug

Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA


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


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


Zydus Lifesciences receives final approval from USFDA for Cyanocobalamin Injection
Drug Approval | April 18, 2022

Zydus Lifesciences receives final approval from USFDA for Cyanocobalamin Injection

The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat


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


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)