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<![CDATA[FDA Grants Orphan Drug Designation to Utidelone in Pancreatic Cancer]]>
26 Sep 2025 21:30 GMT
… ) has reportedly granted orphan drug designation to utidelone for … product, previously received orphan drug designation from the … or condition, with orphan drug designation qualifying sponsors for … -brain-metastasis-drug-orphan-drug-designation
“Designating an …
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Biostar Pharma’s Utidelone Receives Third Orphan Drug Designation from FDA for Pancreatic Cancer
26 Sep 2025 19:32 GMT
… candidate, Utidelone, has been granted Orphan Drug Designation (ODD) by the U …
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HIRA calls for insurance overhaul to ensure access to high-cost orphan drugs
26 Sep 2025 06:13 GMT
… system, Lee said.
“Orphan drugs now constitute the majority … . Last year, 26 orphan drugs were approved domestically, accounting … the approval and review of orphan drugs is similarly “humanitarian” … this principle. Since orphan drugs are high-cost new …
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The FDA Granted Orphan Drug Designation to Biostar Pharma’s Utidelone for the Treatment of Pancreatic Cancer
25 Sep 2025 16:48 GMT
… once again been granted as Orphan Drug Designation (ODD) by the U … 9.57 months.
About Orphan Drug
An orphan drug is used to treat a … ,000 patients in the US. Orphan drug development presents several major challenges …
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<![CDATA[FDA Grants Utidelone Injection Orphan Drug Designation for Pancreatic Cancer]]>
25 Sep 2025 16:11 GMT
… utidelone has previously received orphan drug designation for the treatment … the FDA granted orphan drug designation to utidelone injection … 2 trials.
The orphan drug designation for utidelone in …
The FDA granted orphan drug designation to Biostar Pharma …
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Cure Rare Disease’s CRD-003 designated orphan drug for LGMD2i/R9
25 Sep 2025 15:54 GMT
… ;psychiatric
The FDA has awarded orphan drug designation to Cure Rare Disease … ;congenital Neurology/psychiatric FDA Orphan drug
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People with Medicare Will Face Higher Costs for Some Orphan Drugs Due to Changes in the New Tax and Budget Law
24 Sep 2025 23:32 GMT
… ) for orphan drugs already on the market.
What is the orphan drug exclusion and … law include broadening the orphan drug exclusion to make orphan drugs that are designated … other medications
Changes to the orphan drug exclusion will take effect beginning …
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UPSC Key: MiG-21, India-EU strategic agenda, and Special and Differential Treatment of WTO
27 Sep 2025 12:03 GMT
… patent expiry”, gene therapy drugs, orphan drugs and complex excipients.
Do You …
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<![CDATA[Final Data Show Continued Responses, Safety by Mitazalimab in Pancreatic Cancer]]>
26 Sep 2025 21:49 GMT
… 52%, resulting in an FDA orphan drug designation for pancreatic cancer by …
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<![CDATA[FDA Drops REMS Requirement for Vandetanib in Medullary Thyroid Cancer]]>
26 Sep 2025 19:19 GMT
… .com/ms9ewb3c
FDA approves orphan drug vandetanib. News release. AstraZeneca. April …