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

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

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

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

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

Sinopia Biosciences scores NIH grant to supercharge AI-driven drug discovery

The funding will accelerate Sinopia’s data-driven drug discovery efforts

Amneal and mAbxience score FDA green light for two Denosumab biosimilars

Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma

The FDA aims to make a decision by April 8, 2026

Pfizer’s therapy scores major win in Phase 3 trial for Hemophilia patients with inhibitors

HYMPAVZI’s safety profile was generally favorable

Novartis scores FDA nod for game-changing SMA treatment

Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA