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RSS FeedPosted by Michael Wonder on 20 Feb 2025
Clarity receives US FDA fast track designation for the treatment of metastatic castration resistant prostate cancer patients with copper Cu 67 SAR-bisPSMA
19 February 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 19 Feb 2025
Ultragenyx announces FDA acceptance and priority review of the biologics license application for UX111 AAV gene therapy to treat Sanfilippo syndrome type A
18 February 2025 - FDA decision expected by 18 August 2025. ...
Posted by Michael Wonder on 18 Feb 2025
US FDA accepts Gilead’s new drug applications for twice yearly lenacapavir for HIV prevention under priority review
18 February 2025 - FDA to review applications under priority review, with a PDUFA date of 19 June 2025. ...
Posted by Michael Wonder on 18 Feb 2025
Chimerix announces FDA acceptance and priority review of new drug application for dordaviprone as treatment for recurrent H3 K27M mutant diffuse glioma
18 February 2025 - PDUFA target action date of 18 August 2025. ...
Posted by Michael Wonder on 18 Feb 2025
Dupixent (dupilumab) sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid
18 February 2025 - If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the US; ...
Posted by Michael Wonder on 14 Feb 2025
LIB Therapeutics announces FDA acceptance of biologics license application for lerodalcibep to lower LDL-cholesterol across broad patient population
10 February 2025 - FDA has set a PDUFA target action date of 12 December 2025. ...
Posted by Michael Wonder on 13 Feb 2025
FDA approves Roche’s Evrysdi tablet as first and only tablet for spinal muscular atrophy
12 February 2025 - New tablet formulation may provide greater freedom and independence for people with spinal muscular atrophy thanks ...
Posted by Michael Wonder on 12 Feb 2025
FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma
12 February 2025 - On 11 February 2025, the FDA approved brentuximab vedotin (Adcetris, Seagen) in combination with lenalidomide and a ...
Posted by Michael Wonder on 11 Feb 2025
Biohaven announces FDA acceptance and priority review of troriluzole new drug application for the treatment of spinocerebellar ataxia
11 February 2025 - Troriluzole demonstrated a 50-70% slowing of spinocerebellar ataxia disease progression on the primary and secondary outcome measures at ...
Posted by Michael Wonder on 11 Feb 2025
Linvoseltamab BLA accepted for FDA review for the treatment of relapsed/refractory multiple myeloma
11 February 2025 - FDA decision expected by 10 July 2025. ...
Posted by Michael Wonder on 07 Feb 2025
FDA grants priority review to Insmed's brensocatib for treatment of bronchiectasis
6 February 2025 - Brensocatib would be the first and only available treatment for bronchiectasis and first DPP1 inhibitor, if ...
Posted by Michael Wonder on 03 Feb 2025
US FDA accepts biologics license application for HLX11, biosimilar candidate of Perjeta (pertuzumab)
2 February 2025 - Shanghai Henlius Biotech announced that the US FDA has accepted the biologics license application for HLX11, ...
Posted by Michael Wonder on 02 Feb 2025
US FDA approves Celltrion's Avtozma (tocilizumab-anoh), a biosimilar to Actemra
30 January 2025 - Approval was received for multiple indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic ...
Posted by Michael Wonder on 30 Jan 2025
Ironwood Pharmaceuticals initiates apraglutide NDA submission
29 January 2025 - Initiated rolling new drug application submission, now to include long-term extension data given continued clinical improvement over ...
Posted by Michael Wonder on 29 Jan 2025
Scholar Rock submits biologics license application to the US FDA for apitegromab as a treatment for patients with spinal muscular atrophy
29 January 2025 - Scholar Rock’s BLA submission is based on the Phase 3 SAPPHIRE trial that demonstrated a statistically significant ...