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 11 Apr 2022
Drug pricing with evidence development
11 April 2022 - The policy controversy surrounding aducanumab for Alzheimer disease has shifted from the FDA, which authorised the ...
Posted by Michael Wonder on 11 Apr 2022
Health Canada approves Gardasil 9 (human papillomavirus 9 valent vaccine, recombinant) for the prevention of oropharyngeal and other head and neck cancers
11 April 2022 - Gardasil 9 is the first vaccine in Canada approved for the prevention of HPV related oropharyngeal ...
Posted by Michael Wonder on 11 Apr 2022
A review of patient reported outcome labelling of FDA approved new drugs (2016-2020): counts, categories and comprehensibility
8 April 2022 - A review of new drug approvals by the U.S. FDA for 2006 to 2015 showed that approximately ...
Posted by Michael Wonder on 11 Apr 2022
SMC - April 2022 decisions
12 April 2022 - Advice on three new medicines for use in conditions including a rare and fatal genetic condition affecting ...
Posted by Michael Wonder on 11 Apr 2022
Eton Pharmaceuticals announces FDA approval of cysteine hydrochloride injection
11 April 2022 - Eton Pharmaceuticals today announced that it has received final approval from the U.S. FDA for its cysteine ...
Posted by Michael Wonder on 11 Apr 2022
Poxel announces PXL770 awarded FDA fast track designation for X-linked adrenoleukodystrophy
11 April 2022 - Poxel is pleased to announce that the U.S. FDA has granted fast track designation to PXL770 ...
Posted by Michael Wonder on 11 Apr 2022
UK patients granted early access for radioligand therapy in advanced prostate cancer
8 April 2022 - Advanced Accelerator Applications has announced that eligible patients in the UK have been granted early access ...
Posted by Michael Wonder on 11 Apr 2022
Pfizer’s ALK targeted therapy Lorviqua passes reimbursement review
8 April 2022 - Pfizer’s Lorviqua (lorlatinib), a third generation anaplastic lymphoma kinase (ALK) targeted therapy, passed the review for ...
Posted by Michael Wonder on 11 Apr 2022
Orchard Therapeutics announces reimbursement agreement making Libmeldy available for all eligible MLD patients in Italy
11 April 2022 - Orchard Therapeutics today announced it has reached another historic reimbursement agreement with the Italian Medicines Agency, also ...
Posted by Michael Wonder on 11 Apr 2022
Spectrum Pharmaceuticals announces FDA acceptance of BLA resubmission for eflapegrastim
11 April 2022 - FDA has assigned 9 September 2022 as the PDUFA date. ...
Posted by Michael Wonder on 11 Apr 2022
Hugel says FDA’s complete response letter will not affect Letybo approval
11 April 2022 - Hugel said a complete response letter from the U.S. FDA on botulinum toxin Letybo requires supplementary ...
Posted by Michael Wonder on 11 Apr 2022
Alzheimer's drug makers seek accelerated FDA review despite U.S. coverage decision
8 April 2022 - Eisai and Eli Lilly on Friday said they still plan to seek accelerated U.S. approval for ...
Posted by Michael Wonder on 11 Apr 2022
8,700 more Pacific peoples need treatment to prevent gout each year to achieve equity
11 April 2022 - PHARMAC has released the Pacific peoples health – Gout data insights report today. ...
Posted by Michael Wonder on 11 Apr 2022
Drug makers pledge speedier European market launches to avert stricter regulation
11 April 2022 - Drug makers on Monday pledged to speed up the market launch of new drugs in underserved ...
Posted by Michael Wonder on 11 Apr 2022
New COVID-19 oral treatment on PBS
11 April 2022 - Greg Hunt's swan song press release. ...