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Results For "FDA-approval"

460 News Found

DCGI approves Enzene biosimilar Denosumab for Osteoporosis
Drug Approval | August 28, 2021

DCGI approves Enzene biosimilar Denosumab for Osteoporosis

This is Enzene Biosciences third biosimilar to be approved


US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction
Drug Approval | August 20, 2021

US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction

New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US


Semglee approval to provide huge opportunities in the US insulin biosimilar market
Biotech | August 19, 2021

Semglee approval to provide huge opportunities in the US insulin biosimilar market

FDA approval of the first interchangeable biosimilar insulin will drive the US Insulin biosimilar market, says Kuick Research.


Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.


Novatek Pharma initiates Phase II study of oral COVID-19 drug
Drug Approval | August 14, 2021

Novatek Pharma initiates Phase II study of oral COVID-19 drug

This therapy may provide the first potential oral treatment for COVID-19, recognizing the global emergency of new SARS-CoV-2 variants


Eagle Pharmaceuticals announces licensing agreement for Landiolol
Biotech | August 10, 2021

Eagle Pharmaceuticals announces licensing agreement for Landiolol

Deal signed with AOP Orphan for US commercial rights


Amring Pharmaceuticals launch Isoproterenol Hydrochloride Injection USP
News | August 10, 2021

Amring Pharmaceuticals launch Isoproterenol Hydrochloride Injection USP

The drug is indicated for mild and transient episodes of heart block


Granules clears US FDA audit
News | July 21, 2021

Granules clears US FDA audit

The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021


Sun Pharma settles patent litigation for Revlimid
News | June 23, 2021

Sun Pharma settles patent litigation for Revlimid

Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain generic lenalidomide capsules


Sun Pharma Q4 FY21 net profit up 124%
News | May 27, 2021

Sun Pharma Q4 FY21 net profit up 124%

The company reported net profit for FY21 at Rs. 2,903.8 crore, lower by 23% over last year