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

487 News Found

Eagle Pharmaceuticals announces licensing agreement for Landiolol
Biotech | August 10, 2021

Eagle Pharmaceuticals announces licensing agreement for Landiolol

Deal signed with AOP Orphan for US commercial rights


QIAGEN receives U.S. FDA emergency use authorization to analyze over 30 samples per hour
Digitisation | August 10, 2021

QIAGEN receives U.S. FDA emergency use authorization to analyze over 30 samples per hour

QIAreach SARS-CoV-2 antigen test, developed in collaboration with Ellume, is easy to use and provides accurate and objective results in 2 to 15 minutes


Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal Dx Lung and Colon Cancer Assay
Drug Approval | August 10, 2021

Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal Dx Lung and Colon Cancer Assay

The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients


FDA approves Nexviazyme for late-onset Pompe disease
Drug Approval | August 09, 2021

FDA approves Nexviazyme for late-onset Pompe disease

Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells


Dr Reddy’s relaunch Naproxen Sodium Tablets in the US
News | August 04, 2021

Dr Reddy’s relaunch Naproxen Sodium Tablets in the US

It is part of the company’s pain/analgesics portfolio of OTC products


Abbott receives FDA clearance for its imaging tech using AI
Digitisation | August 04, 2021

Abbott receives FDA clearance for its imaging tech using AI

Ultreon 1.0 Software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using AI -


Abbott's Freestyle Libre 2 Ios App Cleared In U.S
Drug Approval | August 03, 2021

Abbott's Freestyle Libre 2 Ios App Cleared In U.S

FreeStyle Libre 2 iOS app is the only sensor-based glucose monitoring app that allows users to check their glucose with a compatible iPhone every minute with optional real-time glucose alarms


Granules clears US FDA audit
News | July 21, 2021

Granules clears US FDA audit

The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021


Dr. Reddy's Laboratories asked to pay $462.5 mn to Hatchtech
News | June 17, 2021

Dr. Reddy's Laboratories asked to pay $462.5 mn to Hatchtech

The company is exploring all legal options to challenge the award.


NATCO Pharma receives USFDA approval for Lenalidomide capsules
Policy | May 24, 2021

NATCO Pharma receives USFDA approval for Lenalidomide capsules

NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.