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

135 News Found

Dr. Reddy's Laboratories launches Lenalidomide Capsules in the U.S.
News | September 09, 2022

Dr. Reddy's Laboratories launches Lenalidomide Capsules in the U.S.

Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S.


Hikma launches seasonal allergic rhinitis nasal spray RYALTRIS in the US
News | August 31, 2022

Hikma launches seasonal allergic rhinitis nasal spray RYALTRIS in the US

This launch builds upon Hikma’s leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US


Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility
News | August 29, 2022

Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility

The RRA was conducted from 22nd August, 2022 to 26th August, 2022.


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