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Results For "Astellas"

27 News Found

Astellas updates on Fezolinetant application in US
Drug Approval | February 21, 2023

Astellas updates on Fezolinetant application in US

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


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


Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer
Drug Approval | December 20, 2022

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting


Seagen, Astellas and Merck announce results of clinical trial investigating PADCEV with Keytruda  for urothelial cancer
Diagnostic Center | September 13, 2022

Seagen, Astellas and Merck announce results of clinical trial investigating PADCEV with Keytruda for urothelial cancer

Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab


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


Singlera Genomics announces research collaboration with Astellas Pharma
Biotech | April 06, 2022

Singlera Genomics announces research collaboration with Astellas Pharma

The aim is to pursue methylation-based tools to better understand biological reactions to pharmaceuticals


Briefs: Lupin and Aurobindo Pharma
News | May 13, 2024

Briefs: Lupin and Aurobindo Pharma

Lupin updates on shipment of Mirabegron ER Tablets


Lupin launches Mirabegron Extended-Release Tablets in US
Drug Approval | April 22, 2024

Lupin launches Mirabegron Extended-Release Tablets in US

Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US


NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy


USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children
Drug Approval | March 12, 2024

USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children

CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications