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Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer
Drug Approval | January 08, 2026

Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer

Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis


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


Acesion Pharma launches Phase 2 trial for groundbreaking atrial fibrillation therapy
Clinical Trials | January 08, 2026

Acesion Pharma launches Phase 2 trial for groundbreaking atrial fibrillation therapy

The trial aims to measure AF burden—the percentage of time patients spend in arrhythmia—as its primary efficacy endpoint


Alzheimer’s could soon be detected with a simple finger-prick
R&D | January 08, 2026

Alzheimer’s could soon be detected with a simple finger-prick

Blood tests measuring biomarkers such as p-tau217 are emerging as accurate, accessible alternatives


Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer
Drug Approval | January 08, 2026

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations


Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy
R&D | January 08, 2026

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production


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


Briefs: Medicamen Biotech and Gland Pharma
Drug Approval | January 08, 2026

Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)


Dr. Reddy's launches novel recombinant Hepatitis E vaccine ‘Hevaxin’ in India
News | January 07, 2026

Dr. Reddy's launches novel recombinant Hepatitis E vaccine ‘Hevaxin’ in India

It is currently the only vaccine authorized by the Drug Controller General of India (DCGI) for active immunization against HEV in adults aged 18 to 65


Subcutaneous Saphnelo cuts lupus disease activity in phase III trial
Biopharma | January 07, 2026

Subcutaneous Saphnelo cuts lupus disease activity in phase III trial

SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage