Orphan Drug Designation applies to approximately 50,000 Patients who predominantly suffer from severe chronic pain due ...

The FDA granted orphan drug designation to zavabresib, an investigational therapy for the treatment of myelofibrosis, a rare ...

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Imviva Biotech's CTD402 to accelerate the ...

CTD402, an allogeneic CAR T-cell therapy, is designed for immediate administration and targets relapsed/refractory T-ALL and ...

Key market opportunities in the Global Orphan Drugs Market include leveraging regulatory incentives like market exclusivity ...

The FDA granted orphan drug designation to OpCT-001 for the treatment of retinitis pigmentosa, according to a press release ...

Orphan drug designation is granted by the FDA for therapies treating rare disease affecting fewer than 200,000 patients in the U.S., and provides development incentives including extended market ...

Rilzabrutinib is an investigational, oral reversible Bruton tyrosine kinase inhibitor. The Food and Drug Administration (FDA) has granted Orphan Drug designation to rilzabrutinib for the treatment of ...

CMS's third drug negotiation cycle under the IRA targets high-expenditure drugs, impacting Medicare Part B and D spending. The list includes drugs for cancer, HIV, and diabetes, with significant ...

The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease ...

Aug. 1, 2005 — Europe has approved orphan drugs pegylated arginine deiminase for the treatment of hepatocellular carcinoma, soluble yeast beta-1,3/1,6-glucan for the prophylaxis of mucositis due to ...