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Results For "FDA"

2190 News Found

U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer
Drug Approval | October 18, 2021

U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting

IOL receives Korean FDA approval
Drug Approval | October 14, 2021

IOL receives Korean FDA approval

The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead

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

Latest Stories

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

FUJIFILM India unveils four new imaging & healthcare IT solutions at IRIA 2026

White Papers

Chasing Consistency: Centralizing operations data is the key to optimizing chemicals plants

Implementing a digital transformation in chemical operations to maximize profitability

The complexity of compliance

The Sprint to the Summit: Unlocking Lab Efficiency through Digital Transformation

The guiding role of fluidized and spouted bed technologies in particle building processes

Interviews
Only 4-5 Indian pharma companies have a strong presence in Russia, opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
Only 4-5 Indian pharma companies have a strong presence in Russia, opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
Companies must shift from L1 costing to Life Cycle Cost Analysis: Abhilash Pasham, Associate GM - Central Engineering & Projects, Dr. Reddy's Laboratories
Companies must shift from L1 costing to Life Cycle Cost Analysis: Abhilash Pasham, Associate GM - Central Engineering & Projects, Dr. Reddy's Laboratories

Packaging