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Results For "BLA"

264 News Found

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


Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI
News | November 28, 2024

Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI

IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy


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


Roche’s Vabysmo improved vision in underrepresented populations with DME in a first-of-its-kind study
News | October 19, 2024

Roche’s Vabysmo improved vision in underrepresented populations with DME in a first-of-its-kind study

Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies


Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
Drug Approval | October 16, 2024

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally


Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun
News | October 02, 2024

Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun

Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun


AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin
Drug Approval | September 28, 2024

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression


Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis
Drug Approval | September 19, 2024

Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis

This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally


Pfizer highlights diverse oncology portfolio and combination approaches at ESMO 2024
News | September 11, 2024

Pfizer highlights diverse oncology portfolio and combination approaches at ESMO 2024

More than 10 oral and mini-oral presentations span Pfizer’s extensive Oncology portfolio of approved and investigational therapies


AstraZeneca advances ambition to improve standards of care in multiple cancer types
News | September 04, 2024

AstraZeneca advances ambition to improve standards of care in multiple cancer types

Presidential Symposium for NIAGARA will highlight practice-changing impact of a perioperative Imfinzi-based regimen in bladder cancer