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Results For "Food-and-Drug-Administration"

1017 News Found

UK authorises first Covid-19 pill
News | November 05, 2021

UK authorises first Covid-19 pill

Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency


Prime Therapeutics to list Semglee and Insulin Glargine
News | November 05, 2021

Prime Therapeutics to list Semglee and Insulin Glargine

Biocon Biologics and Viatris co-developed the products


U.S. FDA approves ANI’s purified cortrophin gel
Biotech | November 03, 2021

U.S. FDA approves ANI’s purified cortrophin gel

Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016


Dr. Reddy's launches Ephedrine Sulfate injection in the US
Drug Approval | November 01, 2021

Dr. Reddy's launches Ephedrine Sulfate injection in the US

The Akovaz brand and generic market had U.S. sales of approximately US $ 67.5 million MAT for the most recent twelve months ending in August 2021


Samsung Receives FDA clearance for AI algorithms detecting lung nodules in X-rays
Digitisation | November 01, 2021

Samsung Receives FDA clearance for AI algorithms detecting lung nodules in X-rays

It provides an option to automatically perform nodule detection immediately after chest X-ray imaging


Sun Pharma's Winlevi available in the US
Drug Approval | November 01, 2021

Sun Pharma's Winlevi available in the US

It is the first U.S. FDA approved novel topical mechanism for acne in nearly 40 years


Solve.Care and AliveCor partner to connect KardiaMobile users with physicians
Digitisation | October 29, 2021

Solve.Care and AliveCor partner to connect KardiaMobile users with physicians

The collaboration provides KardiaMobile users quick access to doctors worldwide for consultations about their ECG readings


Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial
Biotech | October 28, 2021

Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial

The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population


Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications


Roche’s Susvimo, for `wet’ age-related macular degeneration (nAMD) approved
Drug Approval | October 25, 2021

Roche’s Susvimo, for `wet’ age-related macular degeneration (nAMD) approved

The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months