Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma
Fast Track Designation highlights potential of amezalpat to address unmet need for patients with HCC Amezalpat builds ...
Orphan Drugs Strategic Business Report 2024-2030: Biologics, Oncology & Hospital Pharmacies - The Pulsating Segments of Global Market
Orphan Drugs Market Orphan Drugs Market Dublin, Jan. 22, 2025 (GLOBE NEWSWIRE) -- The "Orphan Drugs - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.The ...
pharmaphorum4d
Orphan drugs: overcoming HTA barriers to access
How can orphan drug manufacturers demonstrate value and improve access to drugs? In this first of two articles on the subject, Ewan Bennett outlines ways to achieve reimbursement in countries ...
News Medical on MSN1d
Ariceum Therapeutics receives FDA’s Orphan Drug Designation for targeted radionuclide cancer treatment
Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the U.S. Food ...
GlobalData on MSN5d
FDA grants orphan drug status to Arbor Biotechnologies’ PH1
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare paediatric disease designation ...
Targeted Oncology4d
FDA Grants 225Ac-SSO110 Orphan Drug Status in SCLC
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
The Pharma Letter1d
BIO applauds introduction of bipartisan ORPHAN Cures Act
The ORPHAN Cures Act (HR 946), a bipartisan bill that removes barriers to treating and curing rare diseases, was reintroduced in the US House of Representative last week.
PharmaTimes5d
FDA grants Orphan Drug Designation to Ariceum cancer therapy
Ariceum Therapeutics, a private biotech company based in Berlin, has announced that the US Food and Drug Administration (FDA) ...
Targeted Oncology13d
FDA Grants Orphan Drug Designation to MB-105 for R/R T-Cell Lymphoma
MB-105, a first-in-class CD5-targeted CAR T-cell therapy, received FDA orphan drug designation for relapsed/refractory T-cell ...
Euractiv6d
Swedish drug agency’s new pricing model surprises, concerns patient and pharma groups
A new drug reimbursement principle is seen as a significant departure from value-based pricing. Despite concerns, the new pricing system could increase the availability of some orphan drugs by 35 per ...
Pharmabiz4d
Ariceum Therapeutics’ proprietary radiopharmaceutical cancer therapy, 225Ac-SSO110 receives US FDA orphan drug designation
Ariceum Therapeutics’ proprietary radiopharmaceutical cancer therapy, 225Ac-SSO110 receives US FDA orphan drug designation: Berlin, Germany Friday, February 7, 2025, 11:00 Hrs [ ...