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Results For "BLA"

416 News Found

Moderna & Merck study: mRNA therapy plus KEYTRUDA cut melanoma recurrence risk by half
R&D | January 21, 2026

Moderna & Merck study: mRNA therapy plus KEYTRUDA cut melanoma recurrence risk by half

The study evaluated patients with stage III/IV melanoma after complete tumor resection


Iksuda reports promising early results for HER2-targeted therapy in oesophageal cancer
Clinical Trials | January 09, 2026

Iksuda reports promising early results for HER2-targeted therapy in oesophageal cancer

The Phase 1 study, a non-randomised, open-label, multicentre trial, is evaluating IKS014 in patients with locally advanced or metastatic solid tumours expressing HER2


Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter
Medical Device | January 08, 2026

Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter

The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures


Alumis reports breakthrough Phase 3 results for oral psoriasis therapy
Clinical Trials | January 08, 2026

Alumis reports breakthrough Phase 3 results for oral psoriasis therapy

The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data


FDA grants priority review to Tzield for youngest Type 1 diabetes patients
Drug Approval | January 07, 2026

FDA grants priority review to Tzield for youngest Type 1 diabetes patients

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D


Incyte eyes first-line nod for Tafasitamab in aggressive lymphoma
News | January 07, 2026

Incyte eyes first-line nod for Tafasitamab in aggressive lymphoma

Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL) in adults, represents 40% of all cases worldwide


FibroBiologics moves experimental psoriasis therapy into FDA review
News | January 04, 2026

FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline


Savara resubmits FDA application for potential treatment in rare lung disease patients
Biopharma | January 01, 2026

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer


SOFIE Biosciences doses first patient in Phase 3 trial of novel cancer imaging agent
Clinical Trials | January 01, 2026

SOFIE Biosciences doses first patient in Phase 3 trial of novel cancer imaging agent

The study will run across 18 sites and enroll roughly 200 patients over 24 months