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Results For "U.S"

1563 News Found

CARsgen Therapeutics opens new U.S. cGMP facility for CAR T production
News | February 22, 2022

CARsgen Therapeutics opens new U.S. cGMP facility for CAR T production

The RTP manufacturing facility will support the company's clinical studies and early commercial launch in North America and Europe


U.S. FDA approves treatment to control pain in cats with osteoarthritis
Drug Approval | January 14, 2022

U.S. FDA approves treatment to control pain in cats with osteoarthritis

It is the first monoclonal antibody drug for use in any animal species


Glenmark receives U.S. FDA approval for Ryaltris
Drug Approval | January 14, 2022

Glenmark receives U.S. FDA approval for Ryaltris

The recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily


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


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


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


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


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


Lupin receives U.S. FDA approval for Sevelamer Carbonate
Drug Approval | December 27, 2021

Lupin receives U.S. FDA approval for Sevelamer Carbonate

This product will be manufactured at Lupin's Goa facility in India