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Results For "US-Food-and-Drug-Administration"

142 News Found

Casper Pharma completed USFDA pre-approval inspection
Drug Approval | July 31, 2022

Casper Pharma completed USFDA pre-approval inspection

The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.


FDA approval of deep brain stimulators will drive APAC market, says GlobalData
News | July 24, 2022

FDA approval of deep brain stimulators will drive APAC market, says GlobalData

Abbott has recently received the US Food and Drug Administration nod to use its DBS device for treatment-resistant depression


Sanofi flu vaccines licensed and approved for 2022-2023 influenza season
Drug Approval | July 05, 2022

Sanofi flu vaccines licensed and approved for 2022-2023 influenza season

Sanofi will begin to ship their vaccines helping to ensure more people will be immunized


OliX Pharmaceuticals submits application to U.S. FDA to evaluate safety and tolerability of OLX10212
Drug Approval | July 04, 2022

OliX Pharmaceuticals submits application to U.S. FDA to evaluate safety and tolerability of OLX10212

The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.


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


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


Novartis Tafinlar and Mekinist demonstrates unprecedented efficacy in pediatric patients
News | June 08, 2022

Novartis Tafinlar and Mekinist demonstrates unprecedented efficacy in pediatric patients

If approved, Tafinlar + Mekinist may offer a potential new standard-of-care for pediatric patients with this brain cancer


GSK to acquire clinical-stage biopharmaceutical company Affinivax for US$ 3.3 billion
News | June 03, 2022

GSK to acquire clinical-stage biopharmaceutical company Affinivax for US$ 3.3 billion

GSK to pay $2.1 billion upfront and up to $1.2 billion in potential development milestones


US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027
Drug Approval | June 01, 2022

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study


USFDA approves Novartis Kymriah CAR-T cell therapy
Biotech | May 29, 2022

USFDA approves Novartis Kymriah CAR-T cell therapy

68% of patients receiving Kymriah in the ELARA trial experienced a complete response, with an 86% overall response rate, along with a remarkable safety profile