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Results For "FDA"

2071 News Found

Ultomiris approved in the US for adults with generalised myasthenia gravis
Drug Approval | April 29, 2022

Ultomiris approved in the US for adults with generalised myasthenia gravis

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks


Medikabazaar teams up with India Health Link
Startup | April 29, 2022

Medikabazaar teams up with India Health Link

To extend the nationwide distribution network for the availability of its proprietary & award-winning HPod for corporates & doctors’ clinics, thereby strengthening India’s phygital wellness ecosystem


Kapruvia approved by European Commission for hemodialysis patients
Drug Approval | April 28, 2022

Kapruvia approved by European Commission for hemodialysis patients

First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients


Sanofi continues to deliver strong business
News | April 28, 2022

Sanofi continues to deliver strong business

Business EPS of €1.94, up 20.5% on a reported basis and 16.1% at CER, also benefitting from an improved effective tax rate


Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance
People | April 27, 2022

Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance

Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)


Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer
Biotech | April 27, 2022

Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers


Zymo invests in Star Array to develop superfast PCR platform
Biotech | April 27, 2022

Zymo invests in Star Array to develop superfast PCR platform

Star Array's focus has been on the development of an automated (cassette-based) nucleic acid purification system coupled with its superfast nucleic acid amplification technology


Malaysia awards three-year contract for Biocon Biologics’ Insugen
Biotech | April 26, 2022

Malaysia awards three-year contract for Biocon Biologics’ Insugen

Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics


‘DREAM-ND’ and ‘DREAM-D’ Phase 3 trials of Desidustat published in American Journal of Nephrology
Biotech | April 25, 2022

‘DREAM-ND’ and ‘DREAM-D’ Phase 3 trials of Desidustat published in American Journal of Nephrology

Desidustat is currently approved only in India as OxemiaTM for patients with CKD induced anemia


Erytech sells U.S. manufacturing facility and enters long-term supply agreement with Catalent
Biotech | April 25, 2022

Erytech sells U.S. manufacturing facility and enters long-term supply agreement with Catalent

Erytech is evaluating valuable strategic options to leverage its Erycaps platform and its development and manufacturing capabilities with complementary assets and/or a broader corporate transaction