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 18 Dec 2022
US FDA approves Vraylar (cariprazine) as an adjunctive treatment for major depressive disorder
16 December 2022 - Approval marks fourth indication for Vraylar, backed by proven efficacy and well-established tolerability as an adjunctive treatment ...
Posted by Michael Wonder on 17 Dec 2022
AbbVie submits supplemental new drug application to US FDA to support new indication of Linzess (linaclotide) for functional constipation in children and adolescents 6 to 17 years of age
16 December 2022 - Submission is based on positive Phase 3 study data demonstrating linaclotide (72 mcg) resulted in increases ...
Posted by Michael Wonder on 16 Dec 2022
Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic oesophagitis
16 December 2022 - If approved, Dupixent would be the first and only targeted medicine specifically indicated for people aged 12 ...
Posted by Michael Wonder on 16 Dec 2022
CSL receives positive CHMP opinion for etranacogene dezaparvovec – gene therapy for adults with haemophilia B
16 December 2022 - Regulatory milestone moves CSL one step closer to bringing the promise of gene therapy for haemophilia ...
Posted by Michael Wonder on 16 Dec 2022
Recommendations made by the PBAC – November 2022
16 December 2022 - The outcomes from the November 2022 PBAC meeting are now available. ...
Posted by Michael Wonder on 16 Dec 2022
Soligenix announces submission of new drug application to the FDA for HyBryte in the treatment of cutaneous T-cell lymphoma
15 December 2022 - Soligenix announced today that it submitted a new drug application to the US FDA for HyBryte (synthetic ...
Posted by Michael Wonder on 15 Dec 2022
Avatrombopag maleate for the treatment of patients with primary chronic immune thrombocytopenia
15 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...
Posted by Michael Wonder on 15 Dec 2022
Fixing price instability can improve access to affordable prescription drugs
15 December 2022 - The high cost of prescription drugs is a very real problem in the US. The average American ...
Posted by Michael Wonder on 15 Dec 2022
Fresenius Kabi receives US FDA approval for biosimilar Idacio (adalimumab)
14 February 2022 - Idacio is a citrate free formulation of adalimumab. ...
Posted by Michael Wonder on 15 Dec 2022
Thea Pharma announces FDA approval of Iyuzeh for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension
15 December 2022 - Iyuzeh (latanoprost ophthalmic solution) 0.005% is the first and only preservative free formulation of latanoprost, the ...
Posted by Michael Wonder on 15 Dec 2022
Esketamine hydrochloride for patients with treatment-resistant depression
14 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...
Posted by Michael Wonder on 15 Dec 2022
FDA approves updated drug labelling including new indications and dosing regimens for capecitabine tablets under Project Renewal
14 December 2022 - Today, the FDA approved updated labelling for capecitabine tablets (Xeloda, Genentech) under Project Renewal, an Oncology Center ...
Posted by Michael Wonder on 15 Dec 2022
PHARMAC consulting on two new medicines for lung cancer
16 December 2022 - PHARMAC has reached provisional agreements with two different suppliers to fund two medicines to treat New Zealanders ...
Posted by Michael Wonder on 15 Dec 2022
Trifluridine with tipiracil hydrochloride for the treatment of patients with metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma after two or more treatments
14 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...
Posted by Michael Wonder on 15 Dec 2022
Pembrolizumab for the neo-adjuvant and adjuvant treatment of patients with early or locally advanced triple negative breast cancer
14 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...