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RSS FeedPosted by Michael Wonder on 24 Feb 2025
US FDA grants fast track designation to Coherent Biopharma’s CBP-1019
21 February 2025 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1019 for the treatment ...
Posted by Michael Wonder on 24 Feb 2025
Auron Therapeutics announces AUTX-703 granted fast track designation by the FDA for relapsed or refractory acute myelogenous leukaemia
24 February 2025 - Auron Therapeutics today announced that the US FDA has granted fast track designation to AUTX-703 for ...
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
PolarityBio receives US FDA breakthrough therapy designation for treatment of Wagner grade I diabetic foot ulcers
20 February 2025 - The FDA has granted breakthrough therapy designation for SkinTE based on key positive data from the Phase ...
Posted by Michael Wonder on 20 Feb 2025
BioRestorative receives FDA fast track designation for BRTX-100 chronic lumbar disc disease program
20 February 2025 - Reflects positive preliminary Phase 2 safety and efficacy data reported to date. ...
Posted by Michael Wonder on 20 Feb 2025
World’s first potential target therapy for diffuse gastric cancer granted fast track designation by the US FDA
20 February 2025 - Signet Therapeutics announced that the US FDA has granted fast track designation for SIGX1094, the world's first ...
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
Doron Therapeutics receives FDA regenerative medicine advanced therapy designation for Motys for treatment of symptoms associated with osteoarthritis
19 February 2025 - Doron Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
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
Fast track granted by FDA for NNZ-2591 in Pitt Hopkins syndrome
19 February 2025 - : Neuren Pharmaceuticals today announced that the US FDA has granted fast track designation for NNZ-2591 ...
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. ...