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351 News Found

European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer
Drug Approval | January 09, 2024

European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer

TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union


Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment
Drug Approval | December 26, 2023

Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment

US FDA approval based on NEURO-TTRansform Phase III results


Pfizer presents marstacimab Phase 3 Data at ASH 2023
News | December 10, 2023

Pfizer presents marstacimab Phase 3 Data at ASH 2023

Demonstrate significant bleed reduction in hemophilia A and B


Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant
News | December 08, 2023

Sarclisa Phase 3 trial met primary endpoint of progression free survival with newly diagnosed multiple myeloma not eligible for transplant

Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone


Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Drug Approval | December 08, 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions


FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric
Drug Approval | November 17, 2023

FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone


SN Bioscience announces Phase 1 study results of SN-38 nanoparticle anti-cancer drug
Diagnostic Center | October 30, 2023

SN Bioscience announces Phase 1 study results of SN-38 nanoparticle anti-cancer drug

Impressive safety and efficacy for solid cancer patients followed by global clinical study plan


USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
Drug Approval | October 26, 2023

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer


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