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Results For "USFDA"

1355 News Found

Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021
News | January 12, 2022

Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021

This surpasses the number of approvals supported in 2020


Molnupiravir best option to treat Covid-19 now: Experts
News | January 11, 2022

Molnupiravir best option to treat Covid-19 now: Experts

Health experts of the country have pointed out that the benefits of the drug outweigh the potential risks it may have in the case of high-risk patients


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