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Results For "approval"

2604 News Found

Veeda Clinical Research files DRHP for Rs 831 crore IPO
News | October 01, 2021

Veeda Clinical Research files DRHP for Rs 831 crore IPO

The issue will consist of the issuance of fresh equity shares worth up to Rs 331.60 crore and an offer for sale (OFS) of Rs 500 crore by promoters and existing shareholders


Natco announces launch of 10 mg Everolimus in the US
Drug Approval | October 01, 2021

Natco announces launch of 10 mg Everolimus in the US

According to industry sales data, the 10mg strength of Afinitor generated annual sales of US $ 392 million during the twelve months ending July 2021


Lupin launches Droxidopa capsules in the US
Drug Approval | September 29, 2021

Lupin launches Droxidopa capsules in the US

Droxidopa capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA


Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology


Cardiovascular devices market to grow at a CAGR of 3.9 % up to 2027
News | September 28, 2021

Cardiovascular devices market to grow at a CAGR of 3.9 % up to 2027

One of the key factors driving the market growth is the rise in the occurrence of chronic cardiovascular diseases such as heart failure and coronary artery disease: Valuates Reports


Tavneos (avacopan) approved for ANCA associated vasculitis in Japan
Drug Approval | September 28, 2021

Tavneos (avacopan) approved for ANCA associated vasculitis in Japan

It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan


U.S. FDA approves Repatha for paediatric patients aged 10 years and older
Drug Approval | September 27, 2021

U.S. FDA approves Repatha for paediatric patients aged 10 years and older

The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients


AstraZeneca Pharma India receives permission for paediatric drug
Drug Approval | September 26, 2021

AstraZeneca Pharma India receives permission for paediatric drug

It paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses


U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans


AstraZeneca to collaborate with VaxEquity for self-amplifying RNA therapy
Biotech | September 24, 2021

AstraZeneca to collaborate with VaxEquity for self-amplifying RNA therapy

saRNA is a new platform for the development of medicines and vaccines which uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level