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342 News Found

Quantum BioPharma completes key toxicity studies for Lucid-MS, paving way for Phase 2 MS trial
Clinical Trials | December 29, 2025

Quantum BioPharma completes key toxicity studies for Lucid-MS, paving way for Phase 2 MS trial

Lucid-MS represents a potential breakthrough in the treatment of multiple sclerosis


SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer
Clinical Trials | December 29, 2025

SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer

The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38


FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia
News | December 27, 2025

FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia

The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia


FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults
Drug Approval | December 24, 2025

FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults

The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo


Hansa Biopharma submits FDA application for kidney transplant desensitization treatment
News | December 24, 2025

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant


Abbott’s Volt PFA System gets FDA nod
News | December 24, 2025

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life


Enveda launches Phase 1 trial for first-in-class Oral IBD therapy
Biotech | December 24, 2025

Enveda launches Phase 1 trial for first-in-class Oral IBD therapy

The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers


FDA go-ahead to Roche’s one-minute follicular lymphoma therapy
Drug Approval | December 23, 2025

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial


FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy
Drug Approval | December 23, 2025

FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy

The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity