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Results For "FDA"

1718 News Found

USFDA permits marketing for new test to improve diagnosis of Alzheimer's disease
News | May 05, 2022

USFDA permits marketing for new test to improve diagnosis of Alzheimer's disease

According to the National Institutes of Health, more than six million Americans, most age 65 or older, may have dementia caused by Alzheimer's disease, a brain disorder known to slowly destroy memory and thinking skills


Eugia Pharma receives USFDA approval for Bortezomib
Drug Approval | May 04, 2022

Eugia Pharma receives USFDA approval for Bortezomib

The approved product has a market size of US $ 1172 million for the twelve months ending March 2022, according to IQVIA


Aleor Dermaceuticals receives USFDA approval for Docosanol Cream
Drug Approval | May 04, 2022

Aleor Dermaceuticals receives USFDA approval for Docosanol Cream

Docosanol Cream, 10% (OTC) has an estimated market size of US$60 million for twelve months ending December 2021 according to IQVIA


USFDA concludes inspection of Shilpa Medicare with four observations
News | May 02, 2022

USFDA concludes inspection of Shilpa Medicare with four observations

The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory


USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis
Drug Approval | May 01, 2022

USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis

The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases


Inmagene receives USFDA's IND clearance for ox40 antagonist
Biotech | May 01, 2022

Inmagene receives USFDA's IND clearance for ox40 antagonist

The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients


Camzyos is the first and only USFDA-approved cardiac myosin inhibitor
Biotech | April 29, 2022

Camzyos is the first and only USFDA-approved cardiac myosin inhibitor

Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo


USFDA grants Breakthrough Device designation to Nocria’s Migraine treatment
Biotech | April 28, 2022

USFDA grants Breakthrough Device designation to Nocria’s Migraine treatment

Nocria’s hand-held device uses gentle, controlled puffs of air in the ears for treating migraine attacks


USFDA approves first Covid-19 treatment for young children
Drug Approval | April 26, 2022

USFDA approves first Covid-19 treatment for young children

This action makes Veklury the first approved Covid-19 treatment for children less than 12 years of age


USFDA clears Franklin Mountain Medical's new dual catheter
Biotech | April 26, 2022

USFDA clears Franklin Mountain Medical's new dual catheter

It enables precise visualization and treatment access to the left heart