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Results For "Food-and-Drug-Administration"

1073 News Found

Adlarity receives USFDA approval for treatment of Alzheimer
Drug Approval | March 14, 2022

Adlarity receives USFDA approval for treatment of Alzheimer

First and only once-weekly patch for convenient, well-tolerated delivery of most used drug for the treatment of Alzheimer's-related dementia


S.M.A.R.T. Radianz Vascular Stent System approved for transradial use in the U.S.
Medical Device | March 13, 2022

S.M.A.R.T. Radianz Vascular Stent System approved for transradial use in the U.S.

It signals Cordis' renewed investment in innovation


New data show Lynparza demonstrated overall survival benefit in early breast cancer
Biotech | March 12, 2022

New data show Lynparza demonstrated overall survival benefit in early breast cancer

Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial


USFDA approves Lupin’s Vigabatrin oral solution
Drug Approval | March 11, 2022

USFDA approves Lupin’s Vigabatrin oral solution

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


Molecular Health and researchers prove new approach to anticipate molecular causation
Biotech | March 10, 2022

Molecular Health and researchers prove new approach to anticipate molecular causation

The studies demonstrate a standardized strategy to extend mechanistic modeling and systems pharmacology into drug safety and mode of action assessments that has relevance for drug development and a variety of other contexts


Zydus Lifesciences subsidiary Sentynl acquires BridgeBio’s Nulibry
Biotech | March 09, 2022

Zydus Lifesciences subsidiary Sentynl acquires BridgeBio’s Nulibry

Nulibry is approved by the U.S. Food and Drug Administration (USFDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder


USFDA approves Evoke Spinal Cord Stimulation System
Drug Approval | March 09, 2022

USFDA approves Evoke Spinal Cord Stimulation System

Transformative closed-loop technology senses the spinal cord's response to stimulation and instantaneously adjusts therapy to sustain durable, optimized treatment


Merck’s KEYTRUDA demonstrates extended relief for patients with resected stage IIB and IIC melanoma
Biotech | March 08, 2022

Merck’s KEYTRUDA demonstrates extended relief for patients with resected stage IIB and IIC melanoma

New results build on previously reported significant recurrence-free survival (rfs) benefit seen in these patients


USFDA approves expanded use of Bristol Myers Opdivo
Drug Approval | March 06, 2022

USFDA approves expanded use of Bristol Myers Opdivo

The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer


Johnson & Johnson Vision Care receives USFDA approval for drug-eluting contact lens
Drug Approval | March 06, 2022

Johnson & Johnson Vision Care receives USFDA approval for drug-eluting contact lens

Novel technology combines ACUVUE daily disposable contact lenses with an established antihistamine in FDA- first in its new category