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RSS FeedPosted by Michael Wonder on 16 Oct 2024
Sellas announces US FDA rare paediatric disease designation granted to galinpepimut-S for the treatment of paediatric acute myeloid leukaemia
15 October 2024 - Galinpepimut-S currently investigated in Phase 3 REGAL trial in adult AML patients – interim analysis anticipated in ...
Posted by Michael Wonder on 15 Oct 2024
Lantern Pharma’s investigational drug candidate, LP-184, receives fast track designation in glioblastoma from the FDA
15 October 2024 - A Phase 1b/2a clinical trial for recurrent glioblastoma is targeted to start in late 2024/early 2025. ...
Posted by Michael Wonder on 15 Oct 2024
The US FDA grants fast track designation to Coherent Biopharma’s CBP-1008
10 October 2024 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1008 for injection (CBP-1008) ...
Posted by Michael Wonder on 14 Oct 2024
UCB receives US FDA approval for 320 mg single injection device presentations of Bimzelx (bimekizumab-bkzx)
14 October 2024 - The new pre-filled syringe and pre-filled auto-injector mean that patients requiring a 320 mg dose of ...
Posted by Michael Wonder on 13 Oct 2024
US FDA approves Dong-A ST’s Imuldosa (ustekinumab-srlf), a biosimilar to Stelara
11 October 2024 - Dong-A ST announced on October 11 2024 that Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara, has won ...
Posted by Michael Wonder on 11 Oct 2024
FDA approves new treatment for haemophilia A or B
11 October 2024 - Product is first non-factor and once weekly treatment for haemophilia B. ...
Posted by Michael Wonder on 10 Oct 2024
Volixibat granted breakthrough therapy designation for cholestatic pruritus in primary biliary cholangitis
10 October 2024 - Designation based on positive interim analysis of Phase 2b VANTAGE study. ...
Posted by Michael Wonder on 10 Oct 2024
FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
10 October 2024 - Today, the FDA approved inavolisib (Itovebi, Genentech) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, ...
Posted by Michael Wonder on 10 Oct 2024
Alnylam submits supplemental new drug application to the US FDA for vutrisiran for the treatment of transthyretin amyloidosis with cardiomyopathy
9 October 2024 - Priority review voucher utilised to accelerate review period. ...
Posted by Michael Wonder on 10 Oct 2024
Capricor Therapeutics announces initiation of rolling submission of biologics license application with US FDA for deramiocel for the treatment of Duchenne muscular dystrophy
9 October 2024 - Company plans to complete rolling BLA submission by end of 2024; application may be eligible for ...
Posted by Michael Wonder on 10 Oct 2024
FDA grants fast track designation for biomarker guided DB104 (liafensine) in patients with treatment resistant depression
9 October 2024 - Denovo Biopharma today announced that the US FDA has granted fast track designation for DB104 (liafensine) being ...
Posted by Michael Wonder on 09 Oct 2024
Biogen receives US FDA breakthrough therapy designation for felzartamab for the treatment of antibody mediated rejection in kidney transplant recipients
9 October 2024 - Designation is based on data from the clinical development program which demonstrated clinical proof of concept. ...
Posted by Michael Wonder on 09 Oct 2024
CPO301 receives fast track designation from the US FDA
8 October 2024 - The board of directors of CSPC Pharmaceutical Group is pleased to announce that CPO301, a first ...
Posted by Michael Wonder on 09 Oct 2024
Zealand Pharma provides US regulatory update on dasiglucagon in congenital hyperinsulinism
9 October 2024 - The re-inspection of the facility was completed in August/September 2024 for which a new inspection classification is ...
Posted by Michael Wonder on 09 Oct 2024
Teva Prolia (denosumab) biosimilar candidate is accepted for review by US FDA and EU EMA
8 October 2024 - TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of ...