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Results For "USFDA"

1159 News Found

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


U.S. FDA approves Leo Pharma’s Adbry
Drug Approval | December 29, 2021

U.S. FDA approves Leo Pharma’s Adbry

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022


Granules Inc., receives ANDA approval for prazosin hydrochloride
Drug Approval | December 28, 2021

Granules Inc., receives ANDA approval for prazosin hydrochloride

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health


Aurobindo to manufacture and market molnupiravir
Drug Approval | December 28, 2021

Aurobindo to manufacture and market molnupiravir

The drug will be marketed under the brand name Molnaflu


Roche gets U.S. FDA nod for at-home Covid-19 self-testing solution
Medical Device | December 27, 2021

Roche gets U.S. FDA nod for at-home Covid-19 self-testing solution

The Covid-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron