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Results For "Food-and-Drug-Administration"

1171 News Found

U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir
News | December 24, 2021

U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir

The authorization provides an additional treatment option against the Covid-19 virus in the form of a pill that can be taken orally


Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


Pfizer’s Covid-19 pill gets U.S. FDA clearance
Drug Approval | December 23, 2021

Pfizer’s Covid-19 pill gets U.S. FDA clearance

Pfizer raises production projections from 80 million to 120 million courses of treatment in 2022, as a result of continued investments to support the manufacturing and distribution of Paxlovid


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


Novartis to acquire Gyroscope Therapeutics for up to US $ 1.5 bn
Biotech | December 22, 2021

Novartis to acquire Gyroscope Therapeutics for up to US $ 1.5 bn

Acquisition will add GT005 to the Novartis portfolio, an investigational, one-time gene therapy currently in Phase 2 for the treatment of people living with Geographic atrophy


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


NMPA approves CStone's NDA for Cejemly
Drug Approval | December 21, 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients


U.S. FDA approves ANI’s rifabutin capsules, launch soon
Drug Approval | December 21, 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin