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 Oct 2024
FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
10 October 2024 - Today, the FDA approved inavolisib (Itovebi, Genentech) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, ...
Posted by Michael Wonder on 10 Oct 2024
Biden-Harris Administration Takes Next Step on Proposed Model to Lower Prescription Drug Costs for People with Medicare
9 October 2024 - Today, the US Department of Health and Human Services, through the Centers for Medicare & Medicaid Services, ...
Posted by Michael Wonder on 10 Oct 2024
Alnylam submits supplemental new drug application to the US FDA for vutrisiran for the treatment of transthyretin amyloidosis with cardiomyopathy
9 October 2024 - Priority review voucher utilised to accelerate review period. ...
Posted by Michael Wonder on 10 Oct 2024
Capricor Therapeutics announces initiation of rolling submission of biologics license application with US FDA for deramiocel for the treatment of Duchenne muscular dystrophy
9 October 2024 - Company plans to complete rolling BLA submission by end of 2024; application may be eligible for ...
Posted by Michael Wonder on 10 Oct 2024
PHARMAC improves access to three cancer medicines
10 October 2024 - PHARMAC will improve access to three cancer medicines from 1 November 2024. ...
Posted by Michael Wonder on 10 Oct 2024
FDA grants fast track designation for biomarker guided DB104 (liafensine) in patients with treatment resistant depression
9 October 2024 - Denovo Biopharma today announced that the US FDA has granted fast track designation for DB104 (liafensine) being ...
Posted by Michael Wonder on 09 Oct 2024
Biogen receives US FDA breakthrough therapy designation for felzartamab for the treatment of antibody mediated rejection in kidney transplant recipients
9 October 2024 - Designation is based on data from the clinical development program which demonstrated clinical proof of concept. ...
Posted by Michael Wonder on 09 Oct 2024
Seizing opportunities in a changing medicines landscape
9 October 2024 - European medicines agencies network strategy to 2028 – launch of public consultation. ...
Posted by Michael Wonder on 09 Oct 2024
Heart attack survivors find new treatment for recurrence risk
4 October 2024 - Mike Lynch was only 12 when his mother died of cardiovascular disease, in the years following he ...
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. ...