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Results For "U.S.-Food-and-Drug-Administration"

489 News Found

USFDA approves first generic version of Apokyn cartridges
Drug Approval | March 02, 2022

USFDA approves first generic version of Apokyn cartridges

TruPharma has commenced commercial marketing of Sage's approved generic cartridge product


Amneal enters U.S. biosimilars market with approval of Releukotm
Drug Approval | March 02, 2022

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022


Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review
Biotech | March 01, 2022

Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review

If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.


USFDA approves CITI Biopharma’s Vonjo
Drug Approval | March 01, 2022

USFDA approves CITI Biopharma’s Vonjo

Vonjo is the first approved therapy to specifically address the needs of adult cytopenic myelofibrosis patients


Europe clears blood test to predict Alzheimer’s disease
Medical Device | February 28, 2022

Europe clears blood test to predict Alzheimer’s disease

It is the first approved blood test that can predict likely progression to Alzheimer's Disease up to six years in advance


USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy
Biotech | February 25, 2022

USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy

Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases


Jardiance approved to treat adults with heart failure regardless of left ventricular ejection fraction
Drug Approval | February 25, 2022

Jardiance approved to treat adults with heart failure regardless of left ventricular ejection fraction

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction


Aadi Bioscience launches Fyarro in the USA
Biotech | February 24, 2022

Aadi Bioscience launches Fyarro in the USA

Fyarro added to NCCN guidelines as the only preferred mTOR inhibitor to treat malignant PEComa


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


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