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Results For "Breakthrough-Therapy-Designation"

75 News Found

Praxis Precision hits milestone in fight against rare paediatric seizures
Clinical Trials | December 08, 2025

Praxis Precision hits milestone in fight against rare paediatric seizures

The EMBOLD study evaluated relutrigine for patients with SCN2A and SCN8A developmental and epileptic encephalopathies


Sound's for hearing loss: Co's drug wins FDA breakthrough tag for Meniere’s disease
Clinical Trials | December 03, 2025

Sound's for hearing loss: Co's drug wins FDA breakthrough tag for Meniere’s disease

Here's a new ray of hope for new hope for patients suffering from Meniere’s disease (MD) and sensorineural hearing loss


FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
Drug Approval | November 21, 2025

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

HER2-mutant NSCLC typically has a poor prognosis and limited treatment options


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