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Results For "Levi-Garraway"

27 News Found

Roche gets FDA approval for Alecensa in early lung cancer
Drug Approval | April 22, 2024

Roche gets FDA approval for Alecensa in early lung cancer

This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy


Positive data for Roche multiple sclerosis injection
Drug Approval | April 17, 2024

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024


New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions with food allergies
Diagnostic Center | February 28, 2024

New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions with food allergies

The U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies


Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results
Drug Approval | December 26, 2023

Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results

If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure


Roche to acquire Carmot Therapeutics for US$ 2.7 billion
News | December 05, 2023

Roche to acquire Carmot Therapeutics for US$ 2.7 billion

Carmot Therapeutics’s R&D portfolio of clinical stage incretins has great potential to treat obesity, diabetes and potentially other diseases


Roche and Alnylam report positive topline results from Phase 2 study KARDIA-1 of zilebesiran
Diagnostic Center | September 11, 2023

Roche and Alnylam report positive topline results from Phase 2 study KARDIA-1 of zilebesiran

Zilebesiran demonstrated an encouraging safety and tolerability profile in adult patients with mild-to-moderate hypertension


USFDA approves Roche’s Columvi for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma
Drug Approval | June 19, 2023

USFDA approves Roche’s Columvi for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma


CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma
Drug Approval | May 02, 2023

CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma


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


Roche gets USFDA approval of Xofluza to treat influenza in children
Drug Approval | August 13, 2022

Roche gets USFDA approval of Xofluza to treat influenza in children

Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age