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 25 Mar 2023
TLV is preparing for an increase in ceiling prices
17 March 2023 - In order to ensure continued good access to medicines for patients, TLV started in the autumn of ...
Posted by Michael Wonder on 25 Mar 2023
MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years
21 March 2023 - The legislative changes will help to make the UK one of the best countries in the world ...
Posted by Michael Wonder on 25 Mar 2023
Incyte provides regulatory update on ruxolitinib extended release tablets
23 March 2023 - Incyte today announced that the US FDA has issued a complete response letter for ruxolitinib extended ...
Posted by Michael Wonder on 25 Mar 2023
FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome
24 March 2023 - The FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta ...
Posted by Michael Wonder on 25 Mar 2023
NICE recommends life-changing gene therapy for children with ultra rare genetic disorder in final draft guidance
23 March 2023 - The first and currently only gene therapy for children with an ultra-rare genetic disorder has been recommended ...
Posted by Michael Wonder on 25 Mar 2023
Lapse of provisional registration for Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic triple negative breast cancer
22 March 2023 - On 22 March 2023, the provisional registration of Tecentriq (atezolizumab) for the treatment of mTNBC will ...
Posted by Michael Wonder on 23 Mar 2023
Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma
23 March 2023 - Across two clinical trials 82% overall response and 35% complete response rate were observed in Chinese ...
Posted by Michael Wonder on 23 Mar 2023
Drug makers push back on a clever tactic employers use to avoid paying for specialty medicines
22 March 2023 - In the face of rising drug prices, health plan sponsors have quietly used a clever, but ...
Posted by Michael Wonder on 23 Mar 2023
Cidara Therapeutics and Melinta Therapeutics announce FDA approval of Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive candidiasis
22 March 2023 - Rezzayo is the first new FDA approved echinocandin in over a decade. ...
Posted by Michael Wonder on 23 Mar 2023
Investments to support access to drugs for rare diseases
22 March 2023 - Today, the Government announced a total investment of up to $1.5 billion over three years in ...
Posted by Michael Wonder on 23 Mar 2023
Government of Canada improves access to affordable and effective drugs for rare diseases
22 March 2023 - Today, the Honourable Jean-Yves Duclos, Minister of Health, announced measures in support of the first-ever National Strategy ...
Posted by Michael Wonder on 23 Mar 2023
PHARMAC considers funding rituximab for IgG4 related disease
23 March 2023 - PHARMAC has initiated a consultation today on widening funded access to rituximab (branded as Riximyo) for ...
Posted by Michael Wonder on 23 Mar 2023
FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma
22 March 2023 - Today the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte) for adult patients with metastatic or ...
Posted by Michael Wonder on 23 Mar 2023
AbbVie provides regulatory update on ABBV-951 (foscarbidopa/foslevodopa) new drug application
22 March 2023 - AbbVie today announced it received a complete response letter from the US FDA for the new ...
Posted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...