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Results For "Food-and-Drug-Administration"

1073 News Found

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


Limited impact of short-term disruptions, growth momentum to continue in FY 23
News | March 03, 2022

Limited impact of short-term disruptions, growth momentum to continue in FY 23

Large players are adequately capitalised to make bigger investments to adjust for the ongoing fundamental shift in market opportunities


Avenge Bio announces peer-reviewed publication on preclinical proof of concept for LOCOcyte platform technology
Biotech | March 03, 2022

Avenge Bio announces peer-reviewed publication on preclinical proof of concept for LOCOcyte platform technology

Ovarian cancer is one of the most difficult cancers to treat. It is typically not detected until later stages, and about 70 percent of patients will have recurrence after an initial treatment, which is often fatal


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


USFDA issues new clinical trial guidelines for cancer treatments
News | March 02, 2022

USFDA issues new clinical trial guidelines for cancer treatments

USFDA's industry recommendations and cancer Moonshot aim to improve lives of patients and their families


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