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 09 Oct 2024
Elafibranor approved as first medicine to treat adults with a rare liver disease known as primary biliary cholangitis
8 October 2024 - The MHRA has approved elafibranor (Iqirvo) to treat adult patients with a rare type of liver disease ...
Posted by Michael Wonder on 09 Oct 2024
MHRA launches 2024/25 business plan with focus on enabling access to groundbreaking new technology while optimising delivery for all who need our services
7 October 2024 - The MHRA has today launched its ambitious new business plan for 2024/25, setting out the agency’s core ...
Posted by Michael Wonder on 09 Oct 2024
CPO301 receives fast track designation from the US FDA
8 October 2024 - The board of directors of CSPC Pharmaceutical Group is pleased to announce that CPO301, a first ...
Posted by Michael Wonder on 09 Oct 2024
Zealand Pharma provides US regulatory update on dasiglucagon in congenital hyperinsulinism
9 October 2024 - The re-inspection of the facility was completed in August/September 2024 for which a new inspection classification is ...
Posted by Michael Wonder on 09 Oct 2024
Teva Prolia (denosumab) biosimilar candidate is accepted for review by US FDA and EU EMA
8 October 2024 - TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of ...
Posted by Michael Wonder on 09 Oct 2024
FDA approves use of up to three tubes of Biofrontera's Ameluz (aminolevulinic acid hydrochloride) 10% topical gel in one treatment
7 October 2024 - Supplemental new drug application supported by two Phase 1 safety studies. ...
Posted by Michael Wonder on 08 Oct 2024
Boehringer receives US FDA breakthrough therapy designation and initiates two Phase 3 trials in MASH for survodutide
8 October 2024 - The US FDA breakthrough therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis ...
Posted by Michael Wonder on 08 Oct 2024
Fruquintinib for patients with previously treated metastatic colorectal cancer
8 October 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 08 Oct 2024
Bimekizumab for the treatment of patients with moderate to severe hidradenitis suppurativa
7 October 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 08 Oct 2024
October 2024 decisions
7 October 2024 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 08 Oct 2024
The FDA approved a self-administered nasal spray for the flu. Here’s how it compares to the traditional flu shot.
6 October 2024 - The US FDA recently approved FluMist as a self or caregiver-administered nasal spray flu vaccine to prevent ...
Posted by Michael Wonder on 08 Oct 2024
Indivior's Sublocade rapid induction/alternative injection site prior approval supplement receives FDA priority review
7 October 2024 - Indivior today announced the prior approval supplement for Sublocade (buprenorphine extended release) injection submitted by Indivior has ...
Posted by Michael Wonder on 08 Oct 2024
New cheaper medicines for auto-immune conditions, cancer and heart disease
8 October 2024 - Australians with types of vasculitis, leukaemia, heart disease, ulcerative colitis and arthritis now have access to ...
Posted by Michael Wonder on 08 Oct 2024
Updated information about PHARMAC's priority lists
8 October 2024 - PHARMAC’s quarterly Pūahoaho Report provides the latest information about applications for medicines, vaccines, and related products that ...
Posted by Michael Wonder on 08 Oct 2024
Neuvivo seeks FDA approval for its breakthrough ALS treatment NP001
7 October 2024 - Neuvivo today announced it submitted a new drug application to the US FDA for NP001 (sodium chlorite ...