Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 13 Jun 2024
FDA grants accelerated approval to repotrectinib for adult and paediatric patients with NTRK gene fusion positive solid tumours
13 June 2024 - Today, the FDA granted accelerated approval to repotrectinib (Augtyro, BMS) for adult and paediatric patients 12 ...
Posted by Michael Wonder on 13 Jun 2024
Receipt of complete response letter from US FDA for ND0612
11 June 2024 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 13 Jun 2024
House dust mite allergen for the treatment of patients with allergic rhinitis and allergic asthma caused by house dust mites (review of TA834)
13 June 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 13 Jun 2024
Innovent receives fast track designation from the US FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer
12 June 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its TOPO1i anti-CLDN18.2 ADC ...
Posted by Michael Wonder on 13 Jun 2024
Comparing new medicine availability across Europe
12 June 2024 - Each year, the European Pharmaceutical Industry Association (EFPIA) publishes data comparing the availability of new medicines across ...
Posted by Michael Wonder on 13 Jun 2024
Baricitinib for the treatment of patients with juvenile idiopathic arthritis
13 June 2024 - NICE is unable to make a recommendation on the use in the NHS of baricitinib (Olumiant) for ...
Posted by Michael Wonder on 13 Jun 2024
Adtralza (tralokinumab) pre-filled pen now available in Canada
12 June 2024 - The single-use 2 mL pre-filled pen is an additional injection choice for administering Adtralza for the ...
Posted 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 12 Jun 2024
Pembrolizumab in combination with trastuzumab and chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastro-oesophageal junction adenocarcinoma (final guidance)
12 June 2024 - NICE has published evidence-based recommendations on the use of pembrolizumab (Keytruda) in combination with trastuzumab and ...
Posted by Michael Wonder on 12 Jun 2024
Voxelotor for the treatment of patients with haemolytic anaemia caused by sickle cell disease
12 June 2024 - NICE has published final evidence-based recommendations on the use of voxelotor (Oxbryta) for the treatment of ...
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
Government ignored funding process with cancer drug promise - former PHARMAC chair
11 June 2024 - The National Party has stepped outside of the drug procurement process when they promised to fund ...
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. ...