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RSS FeedPosted by Michael Wonder on 25 Feb 2025
Glaukos announces FDA acceptance of NDA submission for Epioxa
24 February 2025 - PDUFA date set for 20 October 2025. ...
Posted by Michael Wonder on 24 Feb 2025
US FDA accepts BMS’s supplemental biologics license application for Opdivo plus Yervoy for patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
24 February 2025 - Application based on analyses from the Phase 3 CheckMate-8HW clinical trial, in which Opdivo plus Yervoy demonstrated ...
Posted by Michael Wonder on 21 Feb 2025
Alvotech and Teva announce filing acceptance of US biologics license application for AVT06, a proposed biosimilar to Eylea (aflibercept)
18 February 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review a biologics license ...
Posted by Michael Wonder on 21 Feb 2025
FDA approves first treatment for cerebrotendinous xanthomatosis, a rare lipid storage disease
21 February 2025 - Today, the US FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis in adults. ...
Posted by Michael Wonder on 20 Feb 2025
Harmony Biosciences provides update on the status of the supplemental new drug application for pitolisant in idiopathic hypersomnia
19 February 2025 - Harmony Biosciences today announced that it received a refusal to file letter from the US FDA for ...
Posted by Michael Wonder on 20 Feb 2025
PTC Therapeutics announces FDA acceptance and priority review for vatiquinone NDA for the treatment of children and adults with Friedreich's ataxia
19 February 2025 - PDUFA target action date of 19 August 2025. ...
Posted by Michael Wonder on 20 Feb 2025
Boehringer’s zongertinib receives priority review from US FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer
19 February 2025 - The application for this investigational treatment is based on positive results from the Phase Ib Beamion LUNG-1, ...
Posted 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 ...