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Results For "FDA"

1718 News Found

Aleor receives USFDA approval for Lidocaine and Prilocaine Cream
Drug Approval | April 12, 2022

Aleor receives USFDA approval for Lidocaine and Prilocaine Cream

Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA


All India Institute of Ayurveda signs MoU with Safdarjung hospital
News | April 07, 2022

All India Institute of Ayurveda signs MoU with Safdarjung hospital

The MoU sets down the guidelines for the establishment of an integrative medicine unit, joint research and academic activities in various fields of interest in Ayurveda and modern medicine


Alembic gets USFDA tentative approval for dabigatran etexilate capsules
Drug Approval | April 07, 2022

Alembic gets USFDA tentative approval for dabigatran etexilate capsules

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim


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


Radiaction Medical receives USFDA clearance for its radiation protection system
Medical Device | April 04, 2022

Radiaction Medical receives USFDA clearance for its radiation protection system

It also secures US $ 10 million for US launch and commercialization


USFDA approves Yescarta as first CAR T-cell therapy for Lymphoma
Biotech | April 03, 2022

USFDA approves Yescarta as first CAR T-cell therapy for Lymphoma

Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --


USFDA seeks more analysis on Merck’s BLA for Vaxneuvance
Biotech | April 01, 2022

USFDA seeks more analysis on Merck’s BLA for Vaxneuvance

No new studies have been requested


USFDA approves Edwards Mitris Resilia valve
Medical Device | March 31, 2022

USFDA approves Edwards Mitris Resilia valve

The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve


USFDA approves CartiHeal's implant for the treatment of cartilage and osteochondral defects
Drug Approval | March 30, 2022

USFDA approves CartiHeal's implant for the treatment of cartilage and osteochondral defects

Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of Agili-C™ implant to the current surgical standard of care, debridement and microfracture in the knee joint