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Results For "biologics"

463 News Found

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


Biocon initiates clinical study of Itolizumab for ulcerative colitis in India
Diagnostic Center | December 15, 2022

Biocon initiates clinical study of Itolizumab for ulcerative colitis in India

This is a phase two randomized, double-blind, parallel-group, placebo and active-controlled study


Roche presents new data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022
Diagnostic Center | December 12, 2022

Roche presents new data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022

Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes


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


Lonza collaborates with AbTis to extend Bioconjugation capabilities
Biotech | November 30, 2022

Lonza collaborates with AbTis to extend Bioconjugation capabilities

Collaboration to implement AbTis’ AbClick platform into Lonza’s bioconjugation toolbox


Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)


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


Stelis receives recommendation from EMA granting market authorization for Kauliv
Drug Approval | November 14, 2022

Stelis receives recommendation from EMA granting market authorization for Kauliv

Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.


GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Drug Approval | November 03, 2022

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan