Drug Development Updates

The FDA has approved a new pre-filled syringe formulation of efgartigimod (VYVGART Hytrulo) for self-injection in adults with generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.

FDA Clears ZEISS INTRABEAM 700: Advanced Robotic-Assisted Platform for Intraoperative Radiotherapy

a month ago

ZEISS INTRABEAM 700 has received FDA 510(k) clearance, offering robotic-assisted precision for intraoperative radiation therapy in neuro-oncology and breast cancer treatment.

FDA's April Decisions to Shape Future of Key Therapies: Dupixent, Opdivo, and Nipocalimab in Focus

2 months ago

Several major pharmaceutical companies await critical FDA decisions in April, with Sanofi's Dupixent, Amgen's Uplizna, and Bristol's Opdivo all seeking approval for new indications.

FDA Approves Tremfya for Crohn's Disease and Fabhalta for Rare Kidney Disease Amid Major Pharma Acquisitions

2 months ago

The FDA has approved Johnson & Johnson's Tremfya for moderately to severely active Crohn's disease, marking its fourth indication in the US based on robust data from phase III GALAXI and GRAVITI studies.

Immunovant Shifts Focus to Next-Gen Therapy Despite Positive Phase III Results for Batoclimab in Myasthenia Gravis

2 months ago

Immunovant's batoclimab demonstrated statistically significant improvement in myasthenia gravis symptoms in Phase III trial, with high-dose patients showing a 5.6-point improvement on the MG-ADL scale versus 3.6 points for placebo.

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

Home Terms & Conditions Privacy Policy