Blog
RSS FeedPosted by Michael Wonder on 13 Jun 2024
FDA approves selpercatinib for RET fusion positive thyroid cancer
12 June 2024 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and paediatric patients ...
Posted by Michael Wonder on 12 Jun 2024
Farxiga approved in the US for the treatment of paediatric type 2 diabetes mellitus
12 June 2024 - Approval based on results from T2NOW, one of the largest paediatric type 2 diabetes Phase 3 ...
Posted by Michael Wonder on 11 Jun 2024
Calico Life Sciences announces that fosigotifator (ABBV-CLS-7262) for vanishing white matter disease has been selected for the FDA START pilot program
7 June 2024 -- Calico Life Sciences today announced that its investigational eIF2B activator fosigotifator (ABBV-CLS-7262) has been accepted into ...
Posted by Michael Wonder on 11 Jun 2024
Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis
11 June 2024 - Approval in patients with pJIA weighing 63 kg or greater adds to Kevzara’s position in treating ...
Posted by Michael Wonder on 11 Jun 2024
Ipsen’s Iqirvo receives US FDA accelerated approval as a first in class PPAR treatment for primary biliary cholangitis
10 June 2024 - Approval based on positive Phase 3 ELATIVE trial data. ...
Posted by Michael Wonder on 10 Jun 2024
FDA grants fast track designation to GCBP and Novel Pharma's GC1130A
10 June 2024 - GC Biopharma and Novel Pharma have announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 10 Jun 2024
FDA approves Almirall’s Klisyri (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2
10 June 2024 - Original FDA approval (December 2020) now extended to the use of Klisyri on larger areas of the ...
Posted by Michael Wonder on 10 Jun 2024
Tagrisso granted priority review in the US for patients with unresectable, stage III EGFR mutated lung cancer
10 June 2024 - Decision based on LAURA Phase 3 trial results which extended median progression-free survival by more than ...
Posted by Michael Wonder on 10 Jun 2024
FDA accepts filing of Leqembi (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer's Disease
8 June 2024 - Eisai announced today that that the US FDA has accepted Eisai's supplemental biologics license application for ...
Posted by Michael Wonder on 07 Jun 2024
FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anaemia
6 June 2024 - Today, the FDA approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- ...
Posted by Michael Wonder on 06 Jun 2024
Denali Therapeutics announces FDA has selected DNL126 for MPS IIIA (Sanfilippo syndrome type A) for START pilot program intended to accelerate development of rare disease therapies
3 June 2024 - START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further ...
Posted by Michael Wonder on 06 Jun 2024
Moderna's investigational therapeutic for methylmalonic acidaemia (mRNA-3705) selected by US FDA for START pilot program
6 June 2024 - Center for Biologics Evaluation and Research has chosen mRNA-3705 as one of four investigational medicines for ...
Posted by Michael Wonder on 06 Jun 2024
FDA accepts for review treosulfan NDA resubmission
6 June 2024 - Today, Medexus Pharmaceuticals was informed by medac, licensor of Medexus's commercialisation rights to treosulfan, that the ...
Posted by Michael Wonder on 05 Jun 2024
Catalyst Pharmaceuticals receives US FDA approval for increased maximum daily dose for Firdapse
30 May 2024 - Catalyst Pharmaceuticals today announced that the US FDA has approved its supplemental new drug application increasing the ...
Posted by Michael Wonder on 05 Jun 2024
Why should the FDA focus on pragmatic clinical research?
3 June 2024 - Traditional randomised clinical trials have long been a key tool underpinning drug and device development. ...