FDA News

Listed Orphan Drug Designation In the Month of September 2023: Latest News and Alerts

In the dynamic landscape of pharmaceuticals and healthcare, staying updated on the latest developments in Orphan Drug Designation is of…

1 year ago

All Major Orphan Drug Designation In the Month of August 2023: Latest News and Alerts

In the dynamic landscape of pharmaceuticals and healthcare, staying updated on the latest developments in Orphan Drug Designation is of…

1 year ago

FDA Grants Breakthrough Therapy Designation to Madrigal’s Resmetirom

On April 18, 2023, Madrigal Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its drug candidate resmetirom has received the Breakthrough…

2 years ago

XORTX Announces Receipt of FDA Orphan Drug Designation for ADPKD Treatment

On April 21, 2023, XORTX Therapeutics Inc., a clinical-stage biopharmaceutical company, announced that it has received the Orphan Drug Designation…

2 years ago

FDA Grants Fast Track Designation to Botensilimab Plus Balstilimab in Non–MSI-H/dMMR mCRC

On April 17, 2023, the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034) has been granted fast-track designation by the FDA…

2 years ago

FDA Approves Medtronic MiniMed™ 780G System – World’s First Insulin Pump with Meal Detection Technology

On April 21, 2023, Medtronic plc (NYSE: MDT), a global leader in medical technology, announced FDA approval of its MiniMed…

2 years ago

Luxcreo Launches Luxalign End-To-End Workflow For 3d Printed Clear Aligners

On April 20, 2023, LuxCreo, a leading 3D printing specialist in clear dental appliances, announced an FDA Class II 510(k)…

2 years ago