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5723 News Found

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Bluestem Biosciences files 24 patent applications
News | February 21, 2023

Bluestem Biosciences files 24 patent applications

At commercial scale, Bluestem's patent pending technologies will reduce carbon emission by an estimated 75% or more and be cost-competitive with petroleum based chemicals


Teijin and Axcelead to establish drug discovery research JV
News | February 21, 2023

Teijin and Axcelead to establish drug discovery research JV

The new company will utilize Teijin's drug discovery research technologies, facilities, equipment and personnel.


New data confirm survival benefits of darolutamide in patients with metastatic hormone-sensitive prostate cancer
Clinical Trials | February 21, 2023

New data confirm survival benefits of darolutamide in patients with metastatic hormone-sensitive prostate cancer

New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)


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


Piramal Pharma starts production at new API facility in Riverview, Michigan
News | February 20, 2023

Piramal Pharma starts production at new API facility in Riverview, Michigan

New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)


Dalton ramp ups sterile manufacturing capacity
News | February 20, 2023

Dalton ramp ups sterile manufacturing capacity

The new sterile filling line meets cGMP aseptic filling regulatory requirements


Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
Drug Approval | February 20, 2023

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States


Fluor selected by Agilent for expansion of oligonucleotide manufacturing facility in Colorado
News | February 19, 2023

Fluor selected by Agilent for expansion of oligonucleotide manufacturing facility in Colorado

Fluor is providing architectural and engineering services and procuring equipment for the new 275,000 square-foot manufacturing facility that will house two manufacturing lines to double manufacturing capability


Merck and AstraZeneca present final results from Phase 3 PROpel Trial
Drug Approval | February 18, 2023

Merck and AstraZeneca present final results from Phase 3 PROpel Trial

Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival