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 10 Aug 2021
Final guidance on metastasis-free survival in non-metastatic castration resistant prostate cancer released by the FDA
10 August 2021 - The FDA announced its finalised guidance on the use of metastases-free survival as an outcome for ...
Posted by Michael Wonder on 10 Aug 2021
‘Life-changing’ MS drug costs £600 a month in England but is free on NHS in Scotland
9 August 2021 - Multiple sclerosis patients in England are paying £600 a month for a “life-changing drug” which is ...
Posted by Michael Wonder on 10 Aug 2021
After court defeat, FDA shifts to regulating some drugs as devices
9 August 2021 - The US FDA is informing stakeholders and the public that it will soon begin implementing a ...
Posted by Michael Wonder on 10 Aug 2021
Acer Therapeutics and Relief Therapeutics announce submission of a new drug application to the U.S. FDA for ACER-001 for treatment of urea cycle disorders
9 August 2021 - Acer Therapeutics and Relief Therapeutics today announced the submission of a new drug application to the U.S. ...
Posted by Michael Wonder on 10 Aug 2021
Liminal BioSciences announces sale of priority review voucher for USD105 million
9 August 2021 - Liminal BioSciences announced today that its subsidiary ProMetic Biotherapeutics has entered into a definitive agreement to ...
Posted by Michael Wonder on 10 Aug 2021
Moderna COVID-19 vaccine gets Swiss approval for 12 to 17 year-olds
9 August 2021 - Swissmedic has approved the Moderna COVID-19 vaccine for 12- to 17-year-olds, the Swiss agency said on ...
Posted by Michael Wonder on 10 Aug 2021
Jason Falinski slams TGA’s slow Moderna Covid vaccine approval
10 August 2021 - The TGA took eight months to approve the Moderna Covid-19 vaccine in Australia despite its use in ...
Posted by Michael Wonder on 09 Aug 2021
Scotland backs Bavencio for bladder cancer after NICE says no
9 August 2021 - Patients with bladder cancer in Scotland will be the first in the UK to claim access ...
Posted by Michael Wonder on 09 Aug 2021
Ophthalmologist group wants U.S. Government to push back against Avastin biosimilars
10 August 2021 - The American Academy of Ophthalmology says biosimilar alternatives to Avastin have never been tested in the ...
Posted by Michael Wonder on 09 Aug 2021
HHS proposes nixing Trump rule tying drug costs to foreign rates
7 August 2021 - Issue previously raised in Trump administration. ...
Posted by Michael Wonder on 09 Aug 2021
SMC - August 2021 decisions
9 August 2021 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 09 Aug 2021
Daré Bioscience announces FDA acceptance and priority review of new drug application for DARE-BV1 for the treatment of bacterial vaginosis
9 August 2021 - New drug application supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure ...
Posted by Michael Wonder on 09 Aug 2021
Skyrizi (risankizumab-rzaa) now available in the U.S. as a single 150 mg injection for adults with moderate to severe plaque psoriasis
9 August 2021 - Skyrizi is now the only four-dose-a-year biologic for psoriasis with options to administer via a single-dose pen ...
Posted by Michael Wonder on 09 Aug 2021
Calliditas receives FDA fast track designation for setanaxib in PBC
9 August 2021 - Calliditas Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead NOX ...
Posted by Michael Wonder on 09 Aug 2021
TGA provisionally approves Moderna’s COVID-19 vaccine
9 August 2021 - Today, the Therapeutic Goods Administration, granted provisional approval to Moderna Australia for its COVID-19 vaccine—Spikevax (elasomeran)—making ...