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Results For "Breakthrough-Therapy-Designation"

72 News Found

AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients
Drug Approval | November 21, 2025

AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients

The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study


FDA approves Roche’s kidney inflammation drug
Drug Approval | October 22, 2025

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study


Genmab to acquire Merus for $8 billion
News | October 03, 2025

Genmab to acquire Merus for $8 billion

Proposed acquisition adds petosemtamab, a late-stage asset with two Breakthrough Therapy Designations, to Genmab’s portfolio


Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment
News | September 24, 2025

Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment

Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion


Boehringer’s lung cancer medicine gets FDA approval
Drug Approval | August 12, 2025

Boehringer’s lung cancer medicine gets FDA approval

FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC


Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
News | June 24, 2025

Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

First and only TROP2-directed therapy approved in the US for the treatment of lung cancer


Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer
Drug Approval | May 29, 2025

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition


FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
Drug Approval | April 12, 2025

FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer

The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date