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Results For "approvaL"

2604 News Found

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


US FDA approves Medtronic’s TAVR System
Drug Approval | August 25, 2021

US FDA approves Medtronic’s TAVR System

The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment


Lupin launches Luforbec to treat asthma & COPD in UK
News | August 24, 2021

Lupin launches Luforbec to treat asthma & COPD in UK

It is the first branded generic alternative to Fostair 100/6 pMDI


Aurobindo Pharma calls off its acquisition of Cronus Pharma
News | August 21, 2021

Aurobindo Pharma calls off its acquisition of Cronus Pharma

The acquisition was expected to be completed in eight weeks, and it would have provided it with a foothold in the US $ 48 billion global animal health market


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


AstraZeneca-Sputnik V combination demonstrates high immunogenicity profile: RDIF
Biotech | August 20, 2021

AstraZeneca-Sputnik V combination demonstrates high immunogenicity profile: RDIF

Preliminary data from the first 20 participants in Azerbaijan show antibodies to the SARS-CoV-2 virus spike protein (S-protein) elicited in 100% of cases


Zydus Cadila receives Emergency Use Authorisation for 3-dose ZyCoV-D vaccine
Biotech | August 20, 2021

Zydus Cadila receives Emergency Use Authorisation for 3-dose ZyCoV-D vaccine

This is the world’s first Covid=19 DNA vaccine developed in partnership with DBT-BIRAC


MedAlliance enrols patients for ED study with Sirolimus Drug-Eluting Balloon
Drug Approval | August 19, 2021

MedAlliance enrols patients for ED study with Sirolimus Drug-Eluting Balloon

It is estimated that 300 million men worldwide were affected by ED in 2020, a figure projected to increase to 322 million by 2025. Nearly 30% of these were aged between 40 and 70


FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump
Drug Approval | August 19, 2021

FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump

It measures 9 French (3 millimetres) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min


Ind-Ra predicts growth in US sales for Indian pharma from H2FY22
News | August 18, 2021

Ind-Ra predicts growth in US sales for Indian pharma from H2FY22

Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume