Regulatory

Santhera gains Positive NICE Guidance for AGAMREE® in treating Duchenne Muscular Dystrophy

Santhera has begun launch preparations for AGAMREE® in UK with first sales expected in this quarter ...

IHS achieves approval for global distribution of Insignis™ Infusion System

Rigorous audit paves the way for international availability of advanced infusion technology....

Indian Startup RNT Health Insights Secures Second FDA Breakthrough Designation for AI-Driven Esophageal Cancer Detection Tool

The Chandigarh-based health-tech startup advances gastroenterological diagnostics with its innovative AI-assisted technology, aimed at improving early detection and survival outcomes for esophageal cancer patients....

Innovent secures global licensing deal with Roche for DLL3 antibody drug

Partnership advances development of novel therapies targeting cancer treatment....

FDA grants orphan drug status to MicuRx's MRX-5 for NTM infections.

Designation supports development of innovative treatment for nontuberculous mycobacterial infections....

Spectral AI issues guidelines for retail investors on warrant exercise

Simplifying the Process for Exercising Publicly-Traded Warrants to Maximize Investor Participation....

Polyrizon files U.S. patent for innovative Hydrogel Nasal technologies.

New application highlights advancements in nasal protection and drug delivery solutions....

Microbot Medical ends 2024 with FDA submission for LIBERTY commercialization.

Company achieves major milestones, advancing its robotic surgical system toward market launch....

FDA approves injectable form of Bristol Myers Squibb’s cancer drug Opdivo

New formulation enhances delivery options for advanced cancer treatments. ...

Korean startup Neurophet secures US FDA 510(k) clearance for multiple sclerosis analysis with 'Neurophet AQUA'

Accelerating global expansion with cutting-edge technology targeting multiple sclerosis, a prevalent condition in North America and Europe...