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77 News Found

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


Merck 1Q 2024 sales up 9% to US$ 15.8 billion
News | April 26, 2024

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines


KRAZATI in Combination with Cetuximab demonstrates targeted treatment option for KRAS G12C- colorectal cancer
Diagnostic Center | April 11, 2024

KRAZATI in Combination with Cetuximab demonstrates targeted treatment option for KRAS G12C- colorectal cancer

Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program


Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data
Drug Approval | April 01, 2024

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024


AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer
Diagnostic Center | March 23, 2024

AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer

Combination shows consistent benefit across prespecified post-progression outcomes