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Results For "U.S.-Food-and-Drug-Administration"

594 News Found

Sumitomo Pharma Oncology receives Orphan Drug Designation for DSP-0390 for the treatment of brain cancer
News | July 18, 2022

Sumitomo Pharma Oncology receives Orphan Drug Designation for DSP-0390 for the treatment of brain cancer

The FDA's Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people


Enveda appoints Vanitha Sekar as Chief Business Officer
People | July 16, 2022

Enveda appoints Vanitha Sekar as Chief Business Officer

She joins Enveda from Gilead Sciences


U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | July 15, 2022

U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


Dr. Reddy's Labs launches Fesoterodine Fumarate tablets in US
Drug Approval | July 10, 2022

Dr. Reddy's Labs launches Fesoterodine Fumarate tablets in US

Dr. Reddy's Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.


Pfizer submits new drug application to the U.S. FDA for Paxlovid
Drug Approval | July 03, 2022

Pfizer submits new drug application to the U.S. FDA for Paxlovid

Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk


Weizmann’s study sheds new light on a promising antidepressant
Healthcare | June 30, 2022

Weizmann’s study sheds new light on a promising antidepressant

A newly revealed mechanism by Weizmann Institute of Science of ketamine’s action on potassium channels in neurons may lead to improved therapies for depression


MTPA announces long-term findings from post-marketing safety study of Radicava
News | June 30, 2022

MTPA announces long-term findings from post-marketing safety study of Radicava

Analysis of Post-Marketing Safety Data Shows Consistent Findings with Safety Profile Reported in Clinical Trials of Edaravone


Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine
News | June 30, 2022

Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine

105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses


Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron
News | June 27, 2022

Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron

Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine


ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP
Drug Approval | June 24, 2022

ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP

ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.