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RSS FeedPosted by Michael Wonder on 27 Feb 2024
BeiGene’s biologics license application for Tevimbra (tislelizumab) for first-line gastric or gastro-oesophageal junction cancers accepted by FDA
27 February 2024 - Application based on results from global Phase 3 RATIONALE-305 trial demonstrating Tevimbra plus chemotherapy significantly improved overall ...
Posted by Michael Wonder on 27 Feb 2024
Minerva Neurosciences receives complete response letter from FDA for new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia
27 February 2024 - Minerva Neurosciences announced today that the US FDA has issued a complete response letter to the ...
Posted by Michael Wonder on 27 Feb 2024
US FDA accepts for priority review the supplemental biologics license application for epcoritamab (Epkinly) for difficult to treat relapsed or refractory follicular lymphoma
26 February 2024 - FDA grants priority review with target action date of 28 June 2024. ...
Posted by Michael Wonder on 26 Feb 2024
Bayer receives US FDA breakthrough therapy designation for BAY 2927088 for non-small-cell lung cancer harbouring HER2 activating mutations
26 February 2024 - BAY 2927088 is an oral, small molecule tyrosine kinase inhibitor under development as a potential new targeted ...
Posted by Michael Wonder on 26 Feb 2024
Alvotech and Teva announce US approval of Simlandi (adalimumab-ryvk) injection, the first interchangeable high concentration, citrate free biosimilar to Humira
23 February 2024 - Simlandi is the first citrate free, high concentration biosimilar to be designated interchangeable to Humira in the ...
Posted by Michael Wonder on 24 Feb 2024
Venatorx and Melinta provide update on status of US new drug application for cefepime-taniborbactam
23 February 2024 - No clinical safety or efficacy issues identified. ...
Posted by Michael Wonder on 24 Feb 2024
FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)
23 February 2024 - Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was ...
Posted by Michael Wonder on 23 Feb 2024
Dupixent (dupilumab) sBLA accepted for FDA priority review for treatment of COPD with type 2 inflammation
23 February 2024 - Priority review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be ...
Posted by Michael Wonder on 23 Feb 2024
US FDA grants priority review to Harmony Biosciences' application for Wakix (pitolisant) in paediatric narcolepsy
21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024. ...
Posted by Michael Wonder on 22 Feb 2024
Avidity Biosciences receives FDA rare paediatric disease designation for AOC 1044 for treatment of Duchenne muscular dystrophy in people with mutations amenable to exon 44 skipping
20 February 2024 - Avidity Biosciences today announced that the US FDA has granted rare paediatric disease designation to AOC 1044, ...
Posted by Michael Wonder on 22 Feb 2024
Artiva Biotherapeutics receives FDA fast track designation for AlloNK in lupus nephritis
22 February 2024 - Artiva Biotherapeutics announced today that the US FDA has granted fast track designation to Artiva’s lead ...
Posted by Michael Wonder on 21 Feb 2024
United Therapeutics starts litigation with FDA over rival Liquidia's drug application
21 February 2024 - United Therapeutics said on Wednesday it had filed a case with the US FDA, alleging that ...
Posted by Michael Wonder on 21 Feb 2024
Tecvayli (teclistamab-cqyv) biweekly dosing approved by the US FDA for the treatment of patients with relapsed or refractory multiple myeloma
20 February 2024 - Biweekly dosing with Tecvayli, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility. ...
Posted by Michael Wonder on 21 Feb 2024
Linvoseltamab BLA for treatment of relapsed/refractory multiple myeloma accepted for FDA priority review
21 February 2024 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 21 Feb 2024
FDA and EMA accept vorasidenib regulatory submissions for the treatment of IDH mutant diffuse glioma
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...