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95 News Found

GSK’s experimental lung cancer drug gains FDA orphan drug status
Drug Approval | December 12, 2025

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization


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


Belite Bio reports landmark phase 3 success for Stargardt Disease therapy
Clinical Trials | December 03, 2025

Belite Bio reports landmark phase 3 success for Stargardt Disease therapy

Seeing well-controlled Phase 3 data that shows a marked slowing of lesion growth in Stargardt disease is deeply encouraging


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


Merck to acquire Cidara Therapeutics for $9.2 billion
Biotech | November 15, 2025

Merck to acquire Cidara Therapeutics for $9.2 billion

Diversifying its portfolio to include late-phase antiviral agent


FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency
Drug Approval | November 06, 2025

FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency

Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA


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