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811 News Found

Amgen scores EU nod for UPLIZNA in rare autoimmune disease
News | February 16, 2026

Amgen scores EU nod for UPLIZNA in rare autoimmune disease

The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses


Apotex scores exclusive Canadian rights to testosterone therapy Nebido
News | February 07, 2026

Apotex scores exclusive Canadian rights to testosterone therapy Nebido

Under the agreement, Apotex’s branded division, Searchlight Pharma, will seek regulatory approval and handle marketing and distribution in Canada


Ionis and Otsuka score EU nod for DAWNZERA, offering new hope for rare HAE patients
News | January 28, 2026

Ionis and Otsuka score EU nod for DAWNZERA, offering new hope for rare HAE patients

The EU approval of DAWNZERA is an important milestone that reflects our ongoing commitment to bring this innovative medicine to people in need across the globe


Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients
Drug Approval | January 14, 2026

Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients

The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes


MRM Health scores FDA green light to launch Phase 2b trial of groundbreaking UC therapy
Clinical Trials | January 12, 2026

MRM Health scores FDA green light to launch Phase 2b trial of groundbreaking UC therapy

MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms


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


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


Elanco scores USDA nod for new canine allergy drug Befrena
News | January 04, 2026

Elanco scores USDA nod for new canine allergy drug Befrena

Elanco expects Befrena to launch in the US in the first half of 2026


WORK Medical scores regulatory approval for AI-powered blood analyzer
Medical Device | January 01, 2026

WORK Medical scores regulatory approval for AI-powered blood analyzer

It performs white blood cell differential counts and quantifies red blood cell and platelet morphology,


Co-Diagnostics scores major IP win in Australia with first patent for PCR platform
News | January 01, 2026

Co-Diagnostics scores major IP win in Australia with first patent for PCR platform

The Co-Dx PCR platform is designed to deliver gold-standard PCR accuracy in a compact, user-friendly device suitable for decentralized testing environments