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Results For "USFDA-approval"

194 News Found

Lupin receives USFDA approval for topical solution
Drug Approval | March 03, 2022

Lupin receives USFDA approval for topical solution

The product will be manufactured at Lupin’s facility in Pithampur, India


Medtronic receives USFDA approval for InterStim X system to manage bladder and bowel control
Medical Device | February 23, 2022

Medtronic receives USFDA approval for InterStim X system to manage bladder and bowel control

New InterStim X system provides 10 to 15 years of battery life without the need to recharge


Zydus receives USFDA approval for Dapagliflozin tablets
Drug Approval | February 23, 2022

Zydus receives USFDA approval for Dapagliflozin tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad


Abbott's CardioMEMS HF System receives USFDA approval
Medical Device | February 22, 2022

Abbott's CardioMEMS HF System receives USFDA approval

New expanded indication provides patients suffering from earlier stages of heart failure access to the CardioMEMS HF System, a small implantable sensor that can flag early warning signs of worsening heart failure


Strides receives USFDA approval for Amantadine Hydrochloride capsules
Drug Approval | February 21, 2022

Strides receives USFDA approval for Amantadine Hydrochloride capsules

To be marketed by Strides Pharma Inc. in the US market


Kato wins USFDA approval for studies in retinal disorder
Biotech | February 17, 2022

Kato wins USFDA approval for studies in retinal disorder

Resolv ER may remedy leading causes of blindness in adults


Avion Pharmaceuticals announces USFDA approval of DHIVY
Drug Approval | February 15, 2022

Avion Pharmaceuticals announces USFDA approval of DHIVY

Parkinson's disease treatment is the first and only carbidopa/levodopa (CD/LD) tablet designed to be divided for precise dosing


Azurity Pharma gets USFDA approval for Fleqsuvy
Drug Approval | February 08, 2022

Azurity Pharma gets USFDA approval for Fleqsuvy

Nearly 1 million people are living with multiple sclerosis in the United States. Spasticity is a commonly reported symptom for MS, with an estimated prevalence of spasticity of 67%


Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval
Biotech | February 01, 2022

Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval

Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel


Alembic receives USFDA approval for clarithromycin tablets
Drug Approval | February 01, 2022

Alembic receives USFDA approval for clarithromycin tablets

Clarithromycin tablets USP, 250 mg and 500 mg have an estimated market size of US $ 11 million for twelve months ending September 2021 according to IQVIA