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Results For "FDA"

2328 News Found

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid
Biotech | October 05, 2021

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid

The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)


DentalMonitoring launches ScanBox, an AI-powered orthodontic care device
Medical Device | October 05, 2021

DentalMonitoring launches ScanBox, an AI-powered orthodontic care device

DentalMonitoring, the company that pioneered artificial intelligence in dental and orthodontic care, has announced the launch of the ScanBox


Amber Implants VCFix spinal system receives breakthrough designation
Healthcare | October 05, 2021

Amber Implants VCFix spinal system receives breakthrough designation

The first clinical trial is expected to commence in early 2022 both in Europe and the US


ResMed acquires home sleep testing company Ectosense
Startup | October 05, 2021

ResMed acquires home sleep testing company Ectosense

Ectosense’s NightOwl is a leading cloud-connected home sleep apnea test


Biocon launches Everolimus tablets in the US
Drug Approval | October 04, 2021

Biocon launches Everolimus tablets in the US

According to IQVIA, US sales of Everolimus (Afinitor) tablets were approximately US $ 675 million in the 12 months ending July 2021


Veeda Clinical Research files DRHP for Rs 831 crore IPO
News | October 01, 2021

Veeda Clinical Research files DRHP for Rs 831 crore IPO

The issue will consist of the issuance of fresh equity shares worth up to Rs 331.60 crore and an offer for sale (OFS) of Rs 500 crore by promoters and existing shareholders


Lupin launches Droxidopa capsules in the US
Drug Approval | September 29, 2021

Lupin launches Droxidopa capsules in the US

Droxidopa capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA


MSD India launches 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL 9
Drug Approval | September 29, 2021

MSD India launches 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL 9

India’s first gender-neutral HPV vaccine to help reduce HPV -related disease burden in Indian girls, women and boys


Zebra Medical Vision receives clearance for Coronary Artery Calcium (CAC) solution
Digitisation | September 28, 2021

Zebra Medical Vision receives clearance for Coronary Artery Calcium (CAC) solution

The CAC solution cleared by the U.S. FDA analyses already existing non-gated CT scans and quantifies the coronary artery calcium in order to identify, stratify, and facilitate treatment pathways for patients with cardiovascular disease


Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology