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

489 News Found

NATCO files generic Olaparib Tablets in USA
News | February 14, 2023

NATCO files generic Olaparib Tablets in USA

Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer


Alkem to launch novel antibiotic for MDR infections
News | January 31, 2023

Alkem to launch novel antibiotic for MDR infections

Zidavi is recommended by the Infectious Disease Society of America


FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer
Drug Approval | January 30, 2023

FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer

Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US


Sun Pharma launches SEZABY in the US for treatment of neonatal seizures
News | January 27, 2023

Sun Pharma launches SEZABY in the US for treatment of neonatal seizures

SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection


Astellas announces hold lifted by FDA on Fortis clinical trial of AT845
Drug Approval | January 23, 2023

Astellas announces hold lifted by FDA on Fortis clinical trial of AT845

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients


US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
News | January 23, 2023

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | January 19, 2023

Stelis Biopharma’s flagship facility receives EIR from USFDA

The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes


InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong
Drug Approval | December 31, 2022

InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency


USFDA grants appeal for Ardelyx's XPHOZAH
Drug Approval | December 31, 2022

USFDA grants appeal for Ardelyx's XPHOZAH

Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism


USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine