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 14 Dec 2023
Kyverna Therapeutics granted FDA fast track designation for KYV-101 in the treatment of patients with refractory myasthenia gravis
13 December 2023 - KYV-101 is a fully human CD19 CAR T-cell therapy designed for use in patients with B ...
Posted by Michael Wonder on 13 Dec 2023
Velmanase alfa for the treatment of patients with alfa mannosidosis
13 December 2023 - NICE has published final evidence-based recommendations on the use of velmanase alfa (Lamzede) for treatment of ...
Posted by Michael Wonder on 13 Dec 2023
US diabetes patients face delays as insurers tighten Ozempic coverage
12 December 2023 - Some patients with type 2 diabetes say they are having more difficulty getting reimbursed for drugs ...
Posted by Michael Wonder on 13 Dec 2023
Hutchmed announces continued inclusion of Elunate (fruquintinib) and Sulanda (surufatinib) in the National Reimbursement Drug List in China at current terms
12 December 2023 - Hutchmed today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration, ...
Posted by Michael Wonder on 13 Dec 2023
First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
12 December 2023 - The European Commission, the Heads of Medicines Agencies and EMA have published the first version of the ...
Posted by Michael Wonder on 13 Dec 2023
Japan’s Ministry of Health, Labour and Welfare accepts Arexvy (RSV vaccine) regulatory application to prevent RSV disease in adults aged 50-59 at increased risk
12 December 2023 - Submission supported by positive results of a Phase 3 study showing immune response and safety in adults ...
Posted by Michael Wonder on 13 Dec 2023
Pembrolizumab and chemotherapy with or without bevacizumab for patients with persistent, recurrent or metastatic cervical cancer
13 December 2023 - NICE has published final evidence-based recommendations on the use of pembrolizumab (Keytruda) and chemotherapy with or ...
Posted by Michael Wonder on 13 Dec 2023
MAPS PBC announces submission of new drug application to the FDA for MDMA assisted therapy for PTSD
12 December 2023 - Filing marks first NDA submission for any psychedelic-assisted therapy. ...
Posted by Michael Wonder on 12 Dec 2023
Humacyte submits biologics license application to US FDA seeking approval of human acellular vessel for the treatment of vascular trauma
12 December 2023 - BLA supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the human ...
Posted by Michael Wonder on 12 Dec 2023
Candel Therapeutics receives FDA fast track designation for CAN-2409 in pancreatic cancer
12 December 2023 - Candel Therapeutics today announced that the US FDA granted fast track designation for its lead investigational adenovirus ...
Posted by Michael Wonder on 12 Dec 2023
FDA creates new advisory committee for evaluation of genetic metabolic disease treatments
12 December 2023 - Today, the US FDA announced it is creating a new advisory committee related to potential treatments for ...
Posted by Michael Wonder on 12 Dec 2023
Efgartigimod for the treatment of patients with generalised myasthenia gravis (draft guidance 2)
12 December 2023 - NICE has published further draft guidance on the use of efgartigimod for the treatment of patients ...
Posted by Michael Wonder on 12 Dec 2023
Orchard Therapeutics receives Swissmedic approval for Libmeldy in early-onset MLD
11 December 2023 - Orchard Therapeutics today announced the Swiss Agency for Therapeutic Products (Swissmedic) has approved Libmeldy (atidarsagene autotemcel), a ...
Posted by Michael Wonder on 12 Dec 2023
PHARMAC proposes to fund treatments for breast and blood cancer
12 December 2023 - PHARMAC is seeking feedback on a proposal to fund two new treatments for advanced breast cancer and ...
Posted by Michael Wonder on 12 Dec 2023
FDA and EMA accept marstacimab regulatory submissions for the treatment of haemophilia A and B
11 December 2023 - Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend ...