Blog
RSS FeedPosted by Michael Wonder on 17 Sep 2024
FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma
17 September 2024 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of ...
Posted by Michael Wonder on 17 Sep 2024
ICER to assess treatment for retinitis pigmentosa
17 September 2024 - Report will be subject of New England CEPAC meeting in April 2025; draft scoping document open ...
Posted by Michael Wonder on 17 Sep 2024
FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer
17 September 2024 - Today, the FDA approved ribociclib (Kisqali, Novartis) with an aromatase inhibitor for the adjuvant treatment of ...
Posted by Michael Wonder on 17 Sep 2024
Poseida Therapeutics receives regenerative medicine advanced therapy designation from FDA for P-BCMA-ALLO1 to treat relapsed/refractory multiple myeloma
16 September 2024 - FDA evaluated RMAT application based on positive clinical data from ongoing Phase 1 study of P-BCMA-ALLO1. ...
Posted by Michael Wonder on 14 Sep 2024
A roadmap for improving Medicare’s application of coverage with evidence development
13 September 2024 - The Centers for Medicare and Medicaid Services’ coverage with evidence development policy allows the agency to provide ...
Posted by Michael Wonder on 14 Sep 2024
US FDA grants RPD designation to Senhwa Biosciences silmitasertib for paediatric neuroblastoma
13 September 2024 - Senhwa Biosciences today announced that its new drug silmitasertib (CX-4945) was granted a rare paediatric disease designation ...
Posted by Michael Wonder on 13 Sep 2024
FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for adults and children 12 years and older with moderate to severe atopic dermatitis
13 September 2024 - Ebglyss provides a new first-line biologic treatment for moderate to severe atopic dermatitis that is not well ...
Posted by Michael Wonder on 13 Sep 2024
FDA approves Ocrevus Zunovo as the first and only twice a year 10 minute subcutaneous injection for people with relapsing and progressive multiple sclerosis
13 September 2024 - Ocrevus Zunovo has the potential to expand treatment options to centres without intravenous infrastructure or with intravenous ...
Posted by Michael Wonder on 13 Sep 2024
Dupixent (dupilumab) approved in the US as first and only treatment for adolescents with chronic rhinosinusitis with nasal polyps
13 September 2024 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has approved Dupixent (dupilumab) as an add-on ...
Posted by Michael Wonder on 13 Sep 2024
UnitedHealth to remove AbbVie's Humira from some US drug reimbursement lists next year
10 September 2024 - UnitedHealth Group said on Tuesday it will remove AbbVie’s blockbuster rheumatoid arthritis drug Humira from some ...
Posted by Michael Wonder on 12 Sep 2024
FDA authorises first over the counter hearing aid software
12 September 2024 - Today, the US FDA authorised the first over the counter hearing aid software device, Hearing Aid Feature, ...
Posted by Michael Wonder on 12 Sep 2024
FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
12 September 2024 - Today, the FDA approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) for subcutaneous injection for all the ...
Posted by Michael Wonder on 12 Sep 2024
ICER releases draft evidence report on treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease
12 September 2024 - Public comment period now open until 8 October 2024; requests to make oral comment during public ...
Posted by Michael Wonder on 12 Sep 2024
Tremfya (guselkumab) receives US FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease
11 September 2024 - The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, Tremfya showed highly statistically significant ...
Posted by Michael Wonder on 12 Sep 2024
Ilya Pharma receives rare paediatric disease designation from the US FDA for emilimogene sigulactibac for the treatment of skin wounds in SAVI patients
11 September 2024 - Ilya Pharma today announced that it has received rare paediatric disease designation by the US FDA. ...