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Results For "USFDA"

1203 News Found

Alembic receives tentative U.S.FDA approval for dronedarone tablets
Drug Approval | January 10, 2022

Alembic receives tentative U.S.FDA approval for dronedarone tablets

Dronedarone tablets USP, 400 mg have an estimated market size of US $ 500 million for twelve months ending September 2021 according to IQVIA


Arch Pharmalabs signs agreement with Orchem Technologies to use SMB platform
News | January 10, 2022

Arch Pharmalabs signs agreement with Orchem Technologies to use SMB platform

Simulated Moving Bed (SMB) technology is a highly engineered process for implementing chromatographic separation


Moderna Covid-19 boosters after five-month interval: U.S. FDA
News | January 08, 2022

Moderna Covid-19 boosters after five-month interval: U.S. FDA

Earlier last week the U.S. FDA had also shortened the time to receive a Pfizer booster shot from six months to five months for everyone 12 and older


Aurobindo Pharma rolls out Molnaflu in India
News | January 06, 2022

Aurobindo Pharma rolls out Molnaflu in India

The brand is now available pan-India through their distribution partner


U.S. FDA grants approval for Alembic’s Parkinson’s drug
Drug Approval | January 06, 2022

U.S. FDA grants approval for Alembic’s Parkinson’s drug

Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021, according to IQVIA


Dr Reddy’s molnupiravir priced at Rs 1,400 for a course
News | January 04, 2022

Dr Reddy’s molnupiravir priced at Rs 1,400 for a course

Molflu is expected to be available from early next week in pharmacies throughout the country with a particular focus on states with a high caseload of Covid-19.


Novavax submits data to U.S. FDA for Covid-19 EUA
Biotech | January 03, 2022

Novavax submits data to U.S. FDA for Covid-19 EUA

Emergency Use Authorisation application request to be submitted following one month required by FDA EUA guidance


U.S. FDA grants EUA for Pfizer-BioNTech booster for 12 years and older
News | January 03, 2022

U.S. FDA grants EUA for Pfizer-BioNTech booster for 12 years and older

First emergency use authorization in the United States for a Covid-19 vaccine booster in adolescents 12 through 15 years of age


Quidel’s Antigen tests can detect Omicron variant
Medical Device | December 30, 2021

Quidel’s Antigen tests can detect Omicron variant

The QuickVue antigen tests are able to detect the live Omicron variant with similar performance as with other variants


Siemens Healthineers receive EUA for Covid-19 antigen self-test
Medical Device | December 30, 2021

Siemens Healthineers receive EUA for Covid-19 antigen self-test

Rapid antigen testing provides results in just 15 minutes and the information can help reduce the risk of Covid-19 exposure