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Results For "FDA"

2067 News Found

Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir
News | October 11, 2021

Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir

If authorized, molnupiravir could be the first oral antiviral medicine for the treatment of Covid-19


Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation
Biotech | October 09, 2021

Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022


U.S. FDA clears Venclose Maven to treat incompetent perforator veins
Medical Device | October 07, 2021

U.S. FDA clears Venclose Maven to treat incompetent perforator veins

Next-generation radiofrequency catheter offers first thermal ablation perforator treatment advancement in over 10 years


PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel
Medical Device | October 07, 2021

PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel

RT-PCR test detects and differentiates SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus


Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA
Biotech | October 01, 2021

Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA

The company plans to submit the IND application by the end of 2021


U.S. FDA approves Repatha for paediatric patients aged 10 years and older
Drug Approval | September 27, 2021

U.S. FDA approves Repatha for paediatric patients aged 10 years and older

The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients


U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans


Amaris Clinicals clears U.S. FDA audit
News | September 24, 2021

Amaris Clinicals clears U.S. FDA audit

The company is the Clinical Research Organisation of Caplin Point Laboratories


Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster
Drug Approval | September 23, 2021

Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster

Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups


U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
Drug Approval | September 21, 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States