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3016 News Found

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


Physicians foresee an Alzheimer's Disease treatment revolution supported by advanced testing tools
Biotech | May 02, 2022

Physicians foresee an Alzheimer's Disease treatment revolution supported by advanced testing tools

Blood test for early detection of Alzheimer's Disease (AD) risk will lead to better patient care, physicians say; US. adults call for earlier evaluation and more education


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


Global Cord Blood Corp acquires Cellenkos to advance cell therapy market
Biotech | May 01, 2022

Global Cord Blood Corp acquires Cellenkos to advance cell therapy market

CLNK is a biotechnology research and development company that utilizes umbilical cord blood as the raw material to develop innovative, allogeneic, off-the-shelf, cell based therapeutic products


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


India’s pharma exports grow by 103% since 2013-14
News | May 01, 2022

India’s pharma exports grow by 103% since 2013-14

Pharma exports in 2021-22 sustain a positive growth despite global trade disruptions


Ultomiris approved in the US for adults with generalised myasthenia gravis
Drug Approval | April 29, 2022

Ultomiris approved in the US for adults with generalised myasthenia gravis

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks


Moderna files for authorization of its Covid-19 vaccine in young children six months to six years
Biotech | April 29, 2022

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years

Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children


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


Kapruvia approved by European Commission for hemodialysis patients
Drug Approval | April 28, 2022

Kapruvia approved by European Commission for hemodialysis patients

First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients