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Results For "phase-3"

686 News Found

Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19
News | October 30, 2023

Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19

The companies plan to start a pivotal Phase 3 trial in the coming months


Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer
News | October 25, 2023

Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer

Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada


FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents
Drug Approval | October 21, 2023

FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents

The vaccine further advances Pfizer’s vaccine portfolio and builds on more than 20 years of expertise and knowledge in the prevention of meningococcal disease


USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis
Drug Approval | October 20, 2023

USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis

Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials


Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib
Drug Approval | October 09, 2023

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials


Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for  cell lung cancer
Drug Approval | September 18, 2023

Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for cell lung cancer

Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial


Sun Pharma and Pharmazz ink agreement for introducing Tyvalzi in India
News | September 15, 2023

Sun Pharma and Pharmazz ink agreement for introducing Tyvalzi in India

Sun Pharma is granted rights for marketing Sovateltide in India under the brand name Tyvalzi (Sovateltide)


Insmed announces positive results from Phase III arise study of ARIKAYCE
News | September 06, 2023

Insmed announces positive results from Phase III arise study of ARIKAYCE

Patients Treated with ARIKAYCE plus macrolide-based background regimen had meaningfully larger improvements in QOL-B respiratory score


USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes
Drug Approval | September 01, 2023

USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes

Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia


European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ
Drug Approval | August 30, 2023

European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ

KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population