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

461 News Found

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


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


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


Oragenics announces positive data on Covid-19 intranasal vaccine
Biotech | March 04, 2022

Oragenics announces positive data on Covid-19 intranasal vaccine

Intranasal immunization lowers the viral load below the limit of detection in lungs of hamsters


USFDA issues final guidance on voluntary recalls
News | March 04, 2022

USFDA issues final guidance on voluntary recalls

The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem


USFDA refuses to grant EUA to Covaxin for padeatric use
News | March 04, 2022

USFDA refuses to grant EUA to Covaxin for padeatric use

Covaxin is not approved in the USA for any age group


Cipla gets approval from SEC to conduct Paxlovid trials
News | March 03, 2022

Cipla gets approval from SEC to conduct Paxlovid trials

Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations