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- Orphan Drugs

Orphan Drugs Newsletter

Lion TCR Achieves Triple FDA Milestones with IND Clearance for Chronic Hepatitis B Following Earlier Fast Track and Orphan Drug Designations 15 Sep 2025 02:21 GMT
… ;s earlier regulatory achievements include Orphan Drug designation, which provides incentives for … FDA Fast Track designation and Orphan Drug status, in addition to obtaining … following-earlier-fast-track-and-orphan-drug-designations-302555819.html SOURCE Lion …
Precision Medicine Software Market Trends and Analysis by Application, Vertical, Region, and Segment Forecast to 2029 15 Sep 2025 01:00 GMT
… diseases and the development of orphan drugs, an upsurge in direct-to …
Global T Cell Receptor (TCR) Based Antibody Market to Reach $5.84 Billion at a Steady 17.7% CAGR by 2029 15 Sep 2025 01:45 GMT
… the approvals for rare cancer orphan drugs, a rise in immuno-oncology …
Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus' Phase III CT Waiver Request for Voclosporin 13 Sep 2025 15:24 GMT
… data presented with respect to orphan drug status is anecdotal. Accordingly, the … adequate data to substantiate the orphan drug status in the Indian context …
<![CDATA[FDA Hands Complete Response Letter to SL1009 for Pyruvate Dehydrogenase Complex Deficiency]]> 13 Sep 2025 01:22 GMT
… , SL1009 has received priority review, orphan drug designation, and rare pediatric disease …
Interim results for the six months ended June 30, 2025 12 Sep 2025 12:30 GMT
… study of eRapa in FAP. Orphan Drug Designation granted for eRapa in … , was appointed in March 2025. Orphan Drug Designation for eRapa in FAP …
Belite Bio Announces Completion of DRAGON, a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt Disease 12 Sep 2025 12:00 GMT
… Designations in the U.S.; Orphan Drug Designation in the U.S … designation in the U.S., Orphan Drug Designation in the U.S …
US FDA accepts Corcept Therapeutics’ NDA for relacorilant to treat platinum-resistant ovarian cancer 12 Sep 2025 11:42 GMT
… . It has been designated an orphan drug by the US FDA and …
3 Biotech Stocks Showing Strength With Big Spikes In Momentum Scores 12 Sep 2025 09:53 GMT
… the company’s recently secured Orphan Drug Designation from the European Medicines …
IASO Bio to Present Promising Findings on Equecabtagene Autoleucel for Multiple Sclerosis at both ANA and ECTRIMS 2025 12 Sep 2025 06:46 GMT
… review; It has also received Orphan Drug Designation in South Korea; Registration …

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