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111 News Found

Innovent receives NMPA approval for Taletrectinib Adipate capsule from NMPA
Drug Approval | January 02, 2025

Innovent receives NMPA approval for Taletrectinib Adipate capsule from NMPA

DOVBLERON marks the 13th addition to Innovent’s commercial portfolio


Sanofi acquires rights to develop and commercialize Aficamten in Greater China
News | January 01, 2025

Sanofi acquires rights to develop and commercialize Aficamten in Greater China

In 2020, CORXEL acquired the rights to develop and commercialize aficamten in Greater China


FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy
Drug Approval | December 07, 2024

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients


USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma
Drug Approval | November 25, 2024

USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma

If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse


Blenrep shows overall survival benefit in DREAMM-7 phase III trial for relapsed/refractory multiple myeloma
Clinical Trials | November 19, 2024

Blenrep shows overall survival benefit in DREAMM-7 phase III trial for relapsed/refractory multiple myeloma

Statistically significant and clinically meaningful reduction in the risk of death seen with Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex


USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency
Drug Approval | November 16, 2024

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters


Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD
Drug Approval | September 27, 2024

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype


Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain
Drug Approval | September 06, 2024

Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain

This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II


Dupixent late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM
Clinical Trials | May 21, 2024

Dupixent late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM

Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD


CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine
Drug Approval | April 27, 2024

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU