Orphan Drug Designation applies to approximately 50,000 Patients who predominantly suffer from severe chronic pain due ...
The FDA granted orphan drug designation to CTD402 for relapsed or refractory T-cell acute lymphoblastic leukemia and ...
The FDA granted orphan drug designation to zavabresib, an investigational therapy for the treatment of myelofibrosis, a rare ...
Key market opportunities in the Global Orphan Drugs Market include leveraging regulatory incentives like market exclusivity ...
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 ...
CTD402, an allogeneic CAR T-cell therapy, is designed for immediate administration and targets relapsed/refractory T-ALL and ...
Targeted Delivery: BPM31510 is a CoQ10-lipid nanoparticle conjugate designed for intravenous administration to deliver ...
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 ...
The FDA granted orphan drug designation to OpCT-001 for the treatment of retinitis pigmentosa, according to a press release ...
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 ...
Confirmation Received from MHLW That QRX003 Qualifies for Both Orphan Drug Designation and Fast Track Regulatory Review ...
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 ...
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