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Results For "ANDA"

2079 News Found

USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine
News | August 23, 2021

USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine

The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease


US district court favours Pharmacyclics against Natco on Imbruvica
News | August 20, 2021

US district court favours Pharmacyclics against Natco on Imbruvica

In 2018 NATCO and Alvogen had filed an Abbreviated New Drug Application (ANDA) with PIV certification for the generic version of the product


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


Navia Life Care raises US $ 1 million in Series A funding
Startup | August 20, 2021

Navia Life Care raises US $ 1 million in Series A funding

The company plans to invest in technology, business development, product innovation, and development across India


Health Minister Mr Manshuk Madaviya launch Aarogya Dhara 2.0
Policy | August 19, 2021

Health Minister Mr Manshuk Madaviya launch Aarogya Dhara 2.0

The government plans to enrol over 50 crore people and empanel more hospitals under the scheme. The scheme provides a cover of Rs 5 lakh per family per year


Sai Life Sciences opens discovery biology facility in Hyderabad
Drug Approval | August 19, 2021

Sai Life Sciences opens discovery biology facility in Hyderabad

The company's discovery services support a wide range of global innovator companies from start-ups to large pharma companies, across a diverse set of therapeutic areas including oncology, CNS, antivirals, and inflammation among others


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


Finding a cure for HIV
Drug Approval | August 19, 2021

Finding a cure for HIV

The group, known as the HIV Obstruction by Programmed Epigenetics (HOPE) Collaboratory, will be led by researchers at Gladstone Institutes, Scripps Research Florida, and Weill Cornell Medicine. Their approach, which aims to both silence and permanently remove HIV from the body, takes advantage of knowledge about how other viruses have become naturally inactivated over time.


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


Centre releases Rs 1,300 crores to Northeast states to fight Covid-19
Policy | August 18, 2021

Centre releases Rs 1,300 crores to Northeast states to fight Covid-19

The funds will be used to buy medicines, enhance oxygen supply and augment the bed capacity in the local and district level hospitals