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86 News Found

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Drug Approval | August 01, 2023

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy


Rystiggo needs marketing strategy to fully compete in myasthenia gravis space, says GlobalData
News | June 30, 2023

Rystiggo needs marketing strategy to fully compete in myasthenia gravis space, says GlobalData

Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024


Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss
News | June 28, 2023

Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss

As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands


GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer
Drug Approval | June 12, 2023

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities


Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST
Biotech | June 03, 2023

Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST

Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors


USFDA Advisory Committee votes  n Lynparza plus Abiraterone and Prednisone  for prostate cancer
Drug Approval | May 03, 2023

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients


Pfizer acquisition of ADC trailblazer Seagen a worthy investment: GlobalData
News | March 25, 2023

Pfizer acquisition of ADC trailblazer Seagen a worthy investment: GlobalData

Pfizer’s total cumulative revenue from Seagen therapies is expected to reach $36 billion by 2028, according to GlobalData, a leading data and analytics company.


ENHERTU approved in China for patients with HER2 positive metastatic breast cancer treated withantiHER2-based regimens
News | February 28, 2023

ENHERTU approved in China for patients with HER2 positive metastatic breast cancer treated withantiHER2-based regimens

First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China


Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Drug Approval | February 25, 2023

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma


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