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

461 News Found

IVD system to assist assay developers and clinical labs for molecular diagnostics
Medical Device | November 10, 2021

IVD system to assist assay developers and clinical labs for molecular diagnostics

Thermo Fisher Scientific expands diagnostics portfolio to support full qPCR assay development and testing workflow


US govt places additional order of 1.4 million courses of molnupiravir
News | November 10, 2021

US govt places additional order of 1.4 million courses of molnupiravir

Molnupiravir is an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in at risk adults


Clarivate and BARDA collaborate to identify therapeutics that can be repurposed for medical countermeasures
Biotech | November 09, 2021

Clarivate and BARDA collaborate to identify therapeutics that can be repurposed for medical countermeasures

Bioanalytical approach to accelerate development efforts in the identification of compounds that can treat chlorine or sulfur mustard injuries


Pfizer’s Covid-19 drug a potential game changer
Biotech | November 08, 2021

Pfizer’s Covid-19 drug a potential game changer

In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo


UK authorises first Covid-19 pill
News | November 05, 2021

UK authorises first Covid-19 pill

Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency


Prime Therapeutics to list Semglee and Insulin Glargine
News | November 05, 2021

Prime Therapeutics to list Semglee and Insulin Glargine

Biocon Biologics and Viatris co-developed the products


U.S. FDA approves ANI’s purified cortrophin gel
Biotech | November 03, 2021

U.S. FDA approves ANI’s purified cortrophin gel

Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016


Dr. Reddy's launches Ephedrine Sulfate injection in the US
Drug Approval | November 01, 2021

Dr. Reddy's launches Ephedrine Sulfate injection in the US

The Akovaz brand and generic market had U.S. sales of approximately US $ 67.5 million MAT for the most recent twelve months ending in August 2021


Samsung Receives FDA clearance for AI algorithms detecting lung nodules in X-rays
Digitisation | November 01, 2021

Samsung Receives FDA clearance for AI algorithms detecting lung nodules in X-rays

It provides an option to automatically perform nodule detection immediately after chest X-ray imaging


Sun Pharma's Winlevi available in the US
Drug Approval | November 01, 2021

Sun Pharma's Winlevi available in the US

It is the first U.S. FDA approved novel topical mechanism for acne in nearly 40 years