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Results For "Food-and-Drug-Administration"

1021 News Found

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


Ascentage Pharma gets IND clearance by the US FDA for novel EED Inhibitor APG-5918
Drug Approval | July 02, 2022

Ascentage Pharma gets IND clearance by the US FDA for novel EED Inhibitor APG-5918

This multicenter, open-label Phase I study is designed to assess the safety and tolerability


Lupin receives approval from USFDA for Paliperidone extended-release tablets
Drug Approval | July 01, 2022

Lupin receives approval from USFDA for Paliperidone extended-release tablets

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S


Zydus receives final approval from USFDA for Lacosamide injection
Drug Approval | July 01, 2022

Zydus receives final approval from USFDA for Lacosamide injection

Lacosamide Injection is used to treat partial-onset seizures.


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


Astellas’s update on the Fortis clinical trial of AT845 in adults for pompe disease
Drug Approval | June 27, 2022

Astellas’s update on the Fortis clinical trial of AT845 in adults for pompe disease

The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects


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.