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Results For "phase-3"

686 News Found

Takeda’s dengue vaccine QDENGA approved for use in EU
Drug Approval | December 09, 2022

Takeda’s dengue vaccine QDENGA approved for use in EU

The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022


Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate
News | December 05, 2022

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule


Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer
Drug Approval | November 27, 2022

Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer

Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP
Drug Approval | November 15, 2022

Lynparza in combination with Abiraterone and prednisone receives positive opinion from EU CHMP

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.


Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation
Clinical Trials | October 23, 2022

Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation

Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint


Biocon Biologics signs licensing agreement with Yoshindo
News | October 17, 2022

Biocon Biologics signs licensing agreement with Yoshindo

Yoshindo gets exclusive commercialization rights in Japan for bUstekinumab and bDenosumab developed and manufactured by Biocon Biologics


Glenmark launches Lobeglitazone in India for Uncontrolled Type 2 Diabetes in adults
News | October 07, 2022

Glenmark launches Lobeglitazone in India for Uncontrolled Type 2 Diabetes in adults

Glenmark is the first company in India to launch Thiazolidinedione Lobeglitazone (0.5 mg).


Novartis unveils new focused strategy
News | September 27, 2022

Novartis unveils new focused strategy

Transformation to pure-play Innovative Medicines company nears completion