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Results For "US-Food-and-Drug-Administration"

134 News Found

Ascletis expands ritonavir oral tablet production
Biotech | January 03, 2022

Ascletis expands ritonavir oral tablet production

ASC10 is an oral direct-acting antiviral drug candidate targeting RNA dependent RNA polymerase (RdRp) to treat SARS-CoV-2 infection


Evusheld neutralises Omicron in latest studies
News | December 23, 2021

Evusheld neutralises Omicron in latest studies

Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19


U.S. FDA approves Novartis Leqvio to lower cholestrol
Drug Approval | December 23, 2021

U.S. FDA approves Novartis Leqvio to lower cholestrol

With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction1


Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


U.S. FDA approves first and only injectable option for HIV prevention
Drug Approval | December 21, 2021

U.S. FDA approves first and only injectable option for HIV prevention

Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition


Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research


Zydus receives  USFDA  approval for Phase2(b)/3 trial of Saroglitazar
Biotech | December 10, 2021

Zydus receives USFDA approval for Phase2(b)/3 trial of Saroglitazar

Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)


Boehringer Ingelheim gets CDSCO nod for Jardiance
Drug Approval | November 23, 2021

Boehringer Ingelheim gets CDSCO nod for Jardiance

Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


US govt signs deal with GSK and Vir Biotechnology to buy sotrovimab, a Covid-19 treatment
Biotech | November 18, 2021

US govt signs deal with GSK and Vir Biotechnology to buy sotrovimab, a Covid-19 treatment

The final data from the trial showed sotrovimab reduces hospitalisation and risk of death by 79% in adults with mild-to-moderate Covid-19 who are at high risk of progression to severe disease