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Results For "Food-and-Drug-Administration"

1066 News Found

Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China
Biotech | August 11, 2021

Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China

The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial


GSK files application for MMR vaccine in the US
News | August 11, 2021

GSK files application for MMR vaccine in the US

If approved it will bring a second source of MMR vaccine to the US market


ALS drug RADICAVA holds promise as it completes four years in US
News | August 10, 2021

ALS drug RADICAVA holds promise as it completes four years in US

Nearly 6,000 patients have been treated with the drug since 2017


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


Alkem launches Ibuprofen and Famotidine tablets in US
News | August 07, 2021

Alkem launches Ibuprofen and Famotidine tablets in US

Ibuprofen and Famotidine Tablets is an AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis Tablets, 800 mg/26.6 mg


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


Alkem launch two drugs in US
News | August 04, 2021

Alkem launch two drugs in US

Ibuprofen and Famotidine tablets approved by FDA