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 16 May 2024
Selinexor in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (final guidance)
15 May 2024 - NICE has published final evidence-based recommendations on the use of selinexor (Nexpovio) in combination with bortezomib ...
Posted by Michael Wonder on 16 May 2024
It is time to reconsider the 3% discount rate
15 May 2024 - Health technology assessment guidance often recommends a 3% real annual discount rate, the appropriateness of which ...
Posted by Michael Wonder on 15 May 2024
FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
15 May 2024 - Today, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed ...
Posted by Michael Wonder on 15 May 2024
Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US
14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...
Posted by Michael Wonder on 15 May 2024
Atogepant monohydrate for the prevention of migraine
15 May 2024 - NICE has published final evidence-based recommendations on atogepant monohydrate (Aquipta) for preventing migraine in adults. ...
Posted by Michael Wonder on 15 May 2024
Ascendis Pharma announces extension of US FDA review period for TransCon PTH for adults with hypoparathyroidism
14 May 2024 - PDUFA goal date extended by three months for further review of submission to 14 August 2024. ...
Posted by Michael Wonder on 15 May 2024
Eisai initiates rolling biologics license application to US FDA for Leqembi (lecanemab-irmb) for subcutaneous maintenance dosing
15 May 2024 - BioArctic's partner Eisai announced today that they have initiated the rolling submission of a biologics license application ...
Posted by Michael Wonder on 15 May 2024
ViiV Healthcare announces Health Canada approval for Apretude (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV
13 May 2024 - The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a ...
Posted by Michael Wonder on 15 May 2024
PTC Therapeutics announces FDA acceptance and priority review of the BLA for Upstaza
14 May 2024 - PDUFA target action date of 13 November 2024. ...
Posted by Michael Wonder on 14 May 2024
Baxter secures FDA approval of Clinolipid (lipid injectable emulsion) neonatal and paediatric indication
13 May 2024 - Expanded indication demonstrates Baxter’s continued commitment to meeting the diverse nutritional needs of patients, from preterm neonates ...
Posted by Michael Wonder on 14 May 2024
ICER publishes evidence report on treatment for post-traumatic stress disorder
14 May 2024 - There are substantial uncertainties around the clinical trial results; given the inability to assess net benefit, ...
Posted by Michael Wonder on 14 May 2024
FDA approves updated Altuviiio label with expanded paediatric data confirming highly effective bleed protection in children with haemophilia A
10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data ...
Posted by Michael Wonder on 14 May 2024
Budget 2024–25: cheaper medicines, new Medicare Urgent Care Clinics and more free mental health services in a stronger Medicare
14 May 2024 - The Albanese Labor Government is continuing to improve our health system: strengthening Medicare, the heart of universal ...
Posted by Michael Wonder on 14 May 2024
Sumitomo Pharma announces FDA acceptance of supplemental new drug application for vibegron in men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia
13 May 2024 - Supplemental new drug application submission based on Phase 3 study of vibegron 75 mg (Gemtesa) demonstrating statistically ...
Posted by Michael Wonder on 14 May 2024
Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis
13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...