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RSS FeedPosted 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. ...
Posted by Michael Wonder on 18 Feb 2025
Petosemtamab granted breakthrough therapy designation by the US FDA for first-line PD-L1 positive head and neck squamous cell carcinoma
18 February 2025 - This marks the second breakthrough therapy designation for petosemtamab in head and neck squamous cell carcinoma. ...
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 18 Feb 2025
Rznomics liver cancer drug candidate secures fast track designation
17 February 2025 - Second fast track designation following brain cancer approval. ...
Posted by Michael Wonder on 17 Feb 2025
Innovent receives second fast track designation from the US FDA for IBI363 (PD-1/IL-2α-bias bipspecific antibody fusion protein) in squamous non-small cell lung cancer
17 February 2025 - Innovent Biologics announced that its first in class PD-1/IL-2α-bias bi-specific antibody fusion protein, IBI363, has received its ...
Posted by Michael Wonder on 17 Feb 2025
Innate Pharma announces US FDA granted breakthrough therapy designation to lacutamab for relapsed or refractory Sézary syndrome
17 February 2025 - Designation is based on TELLOMAK Phase 2 results demonstrating efficacy and a favourable safety profile in patients ...
Posted by Michael Wonder on 17 Feb 2025
Out of pocket getting out of hand - reducing the financial toxicity of rapidly approved drugs
15 February 2025 - In 2023, Teresa was diagnosed with amyotrophic lateral sclerosis. Several months later, her family started a GoFundMe ...
Posted by Michael Wonder on 16 Feb 2025
Bavarian Nordic receives US FDA approval of chikungunya vaccine for persons aged 12 and older
14 February 2025 - On track for commercial launch in the US in the first half of 2025. ...
Posted by Michael Wonder on 16 Feb 2025
FDA approves Samsung Bioepis’ Ospomyv, Xbryk (denosumab-dssb), a biosimilar to Prolia and Xgeva
15 February 2025 - Samsung Bioepis’ first endocrinology biosimilar to be approved by the FDA – widening its therapeutic areas and ...
Posted by Michael Wonder on 15 Feb 2025
Penmenvy, GSK’s 5 in 1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY
15 February 2025 - Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect ...