SPK-9001 is a novel, investigation vector containing a bio-engineered ... regenerative medicines advance therapy (RMAT), as well as orphan drug designation by the FDA and PRIority Medicines ...

Bexobrutideg, a bioavailable agent, was granted orphan drug designation by the FDA for Waldenström macroglobulinemia, a type of non-Hodgkin's lymphoma. The orally bioavailable agent bexobrutideg ...

“Obtaining Orphan Drug Designation for PEP-010 marks a significant milestone in our efforts to develop our drug candidate for pancreatic cancer and highlights the significant unmet medical need ...

Paul Verdin, VP of consulting and analytics, and Andreas Hadjivasiliou, managing analyst at Evaluate, tell us about the company’s Orphan Drug Report 2022, which highlights activities within the ...

"We are thrilled to have received Orphan Drug Designation for Batoclimab in Japan, marking an important milestone in our efforts to bring this promising treatment to patients in need," said Sean Jeong ...

Immunotherapy has emerged as one of the major options for cancer treatment in the past decade. With the successful application of immune checkpoint inhibitors and the introduction of immune regulatory ...

The Acclaim-1 and Acclaim-3 clinical trials, which focus on different types of lung cancer, have received FDA Fast Track and Orphan Drug Designations, reflecting their potential significance in ...

Paris (France), March 17, 2025 – PEP-Therapy, a clinical-stage biotechnology company developing first-in-class peptides as targeted therapies in oncology, announced that the U.S. Food and Drug ...

2025 Healthcare & Pharmaceuticalscategory UnitedHealth eases rules on renewing some prescription drugs March 19, 2025 ...