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RSS FeedPosted 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
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 14 Feb 2025
FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes
14 February 2025 - Agency continues efforts to increase access to insulin treatment options. ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves vimseltinib for symptomatic tenosynovial giant cell tumour
14 February 2025 - Today, the FDA approved vimseltinib (Romvimza, Deciphera Pharmaceuticals), a kinase inhibitor, for adult patients with symptomatic ...
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 grants fast track designation to PleoPharma's investigational new drug PP-01 for the mitigation of cannabis withdrawal symptoms in patients with cannabis use disorder: a potential first in class treatment
13 February 2025 - Phase 3 preparations underway. ...
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 13 Feb 2025
US FDA approves expanded label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
12 February 2025 - Izervay dosing approved beyond 12 months. ...