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 01 Jun 2024
New Zealand Pharmaceutical Schedule - 1 June 2024
1 June 2024 - The June 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 May 2024
Moderna receives US FDA approval for RSV vaccine mRESVIA
31 May 2024 - mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes ...
Posted by Michael Wonder on 31 May 2024
Highlights from the 27-30 May 2024 CHMP meeting
31 May 2024 - The EMA’s CHMP recommended 14 medicines for approval at its May 2024 meeting. ...
Posted by Michael Wonder on 31 May 2024
Schedule of Pharmaceutical Benefits - 1 June 2024
1 June 2024 - The June 2024 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 May 2024
FDA plans to release AI drug development guidance this year
30 May 2024 - The US FDA plans to release a draft guidance this year on the use of artificial intelligence/machine ...
Posted by Michael Wonder on 31 May 2024
NH TherAguix receives FDA fast track designation for AGuIX, its novel radio-enhancer in the treatment of malignant gliomas, and provides an update on its developments and prospects
30 May 2024 - Key regulatory milestone confirming the interest of the US authorities in AGuIX, a next generation nanodrug ...
Posted by Michael Wonder on 31 May 2024
Annual report highlights progress in science, medicines and health in 2023
30 May 2024 - EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the ...
Posted by Michael Wonder on 30 May 2024
ICER publishes evidence report on treatment for chronic obstructive pulmonary disease
30 May 2024 - Ensifentrine has a novel mechanism of action for an inhaled therapy; treatment would achieve common thresholds ...
Posted by Michael Wonder on 30 May 2024
Improving our assessments of drugs with companion diagnostic tests
30 May 2024 - As part of our ongoing initiative to improve and modernise our reimbursement review program, Canada’s Drug Agency ...
Posted by Michael Wonder on 30 May 2024
US FDA approves Bristol Myers Squibb’s Breyanzi as a new CAR T-cell therapy for relapsed or refractory mantle cell lymphoma
30 May 2024 - In the MCL cohort of TRANSCEND-NHL-001, Breyanzi delivered responses in 85.3% of patients with a one-time infusion ...
Posted by Michael Wonder on 30 May 2024
Budget 2024 health: no funding for promised cancer drugs disappoints breast cancer patient - extension to screening welcomed
30 May 2024 - A cancer patient is disappointed with a lack of funding for new medicines in Budget 2024, ...
Posted by Michael Wonder on 30 May 2024
European Commission adopts rules for joint clinical assessments
29 May 2024 - The European Commission has adopted joint clinical assessment rules detailing how national health care systems should ...
Posted by Michael Wonder on 30 May 2024
Affimed receives fast track designation for combination therapy of AFM24 with atezolizumab for EGFR wild type non-small cell lung cancer
29 May 2024 - The FDA’s fast track designation was granted after its review of the initial efficacy data of the ...
Posted by Michael Wonder on 30 May 2024
Vyluma announces marketing authorisation application validation for the European Union
29 May 2024 - Vyluma announced today that the EMA has validated the marketing authorisation application for its lead compound, NVK002. ...
Posted by Michael Wonder on 30 May 2024
FDA use of “proxies” to expedite drug approvals not supported by evidence, analysis finds
28 May 2024 - In the world of drug development, there has been a recent movement to speed clinical trials of ...