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Results For "safety"

1408 News Found

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy
Drug Approval | December 14, 2024

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months


Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium
Clinical Trials | December 11, 2024

Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium

Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity (clinical benefit rate


Ichnos Glenmark Innovation presents first clinical data from Phase 1 study of Trispecific TREAT antibody
Clinical Trials | December 10, 2024

Ichnos Glenmark Innovation presents first clinical data from Phase 1 study of Trispecific TREAT antibody

Showing High Overall Response Rate (ORR) with durable responses and favorable safety profile in patients with heavily pretreated multiple myeloma


Merck’s investigational ADC with R-CHP demonstrates 100% response rate for B-cell lymphoma
Clinical Trials | December 09, 2024

Merck’s investigational ADC with R-CHP demonstrates 100% response rate for B-cell lymphoma

Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate


Roche’s Polivy combination therapy sets new standard of care for untreated aggressive lymphoma
Clinical Trials | December 09, 2024

Roche’s Polivy combination therapy sets new standard of care for untreated aggressive lymphoma

Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems


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


FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
Drug Approval | December 06, 2024

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma


Granules India update on USFDA inspection at Gagillapur facility
News | December 05, 2024

Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA


Aster and Blackstone-backed Quality Care to merge and create hospital chains in India
Healthcare | December 04, 2024

Aster and Blackstone-backed Quality Care to merge and create hospital chains in India

Aster DM Healthcare and Quality Care India Limited have signed definitive agreements to merge, subject to regulatory, corporate and shareholders’ approvals


Boehringer Ingelheim launches next generation poultry vaccine in India
Healthcare | November 26, 2024

Boehringer Ingelheim launches next generation poultry vaccine in India

This is recommended for in-ovo vaccination of 18 to 19-day-old embryonated chicken eggs and one-day old chickens to protect against the virulent Marek’s disease