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 30 May 2024
FDA grants priority review to Roche’s inavolisib for advanced hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
29 May 2024 - The target action date for the FDA decision is 27 November 2024. ...
Posted by Michael Wonder on 29 May 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
29 May 2024 - Acceptance based on results from the pivotal Phase 3 CCTG IND.227/KEYNOTE-483 trial, which demonstrated a statistically significant ...
Posted by Michael Wonder on 29 May 2024
FDA grants accelerated approval to selpercatinib for paediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumours
29 May 2024 - Today, the FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly) for certain paediatric patients two ...
Posted by Michael Wonder on 29 May 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
29 May 2024 - Approval based on results from CheckMate-901, the first Phase 3 trial in this patient population with an ...
Posted by Michael Wonder on 29 May 2024
KRPIA urges incoming Assembly to recognise new drugs’ value
28 May 2024 - The Korean Research based Pharma Industry Association (KRPIA) called for the 22nd National Assembly, which is ...
Posted by Michael Wonder on 29 May 2024
Zanubrutinib in combination with obinutuzumab for the treatment of patients with relapsed or refractory B-cell follicular lymphoma after two or more treatments
28 May 2024 - NICE is unable to make a recommendation on the use of zanubrutinib (Brukinsa) in combination with obinutuzumab ...
Posted by Michael Wonder on 29 May 2024
Dabrafenib mesylate in combination with trametinib dimethyl sulphoxide for the treatment of children and adolescents with BRAF V600E mutation positive glioma
29 May 2024 - NICE has published final evidence-based recommendations on the use of dabrafenib mesylate (Finlee) in combination with ...
Posted by Michael Wonder on 29 May 2024
FDA approves first interchangeable biosimilar for two rare diseases
28 May 2024 - Today, the US FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to ...
Posted by Michael Wonder on 29 May 2024
Trastuzumab deruxtecan for the treatment of patients with advanced HER2 mutation positive non-small-cell lung cancer after platinum-based chemotherapy
29 May 2024 - NICE is unable to make a recommendation on the use of trastuzumab deruxtecan (Enhertu) for the treatment ...
Posted by Michael Wonder on 28 May 2024
Vera Therapeutics receives US FDA breakthrough therapy designation for atacicept in immunoglobulin A nephropathy
28 May 2024 - Vera Therapeutics today announced that the US FDA has granted breakthrough therapy designation to atacicept for the ...
Posted by Michael Wonder on 28 May 2024
Vasomune Therapeutics receives US FDA fast track designation for novel investigational medicine AV-001
28 May 2024 - Vasomune Therapeutics has announced today that the US FDA granted fast track designation for AV-001 for the ...
Posted by Michael Wonder on 28 May 2024
David Seymour’s special envoy in medicines is dumping his drug company investments
28 May 2024 - Act MP Todd Stephenson is selling his investments in drug companies while labelling as “outrageous” claims ...
Posted by Michael Wonder on 28 May 2024
Regulator OKs Eisai Korea’s Leqembi for early Alzheimer's disease treatment
27 May 2024 - Eisai Korea said its monoclonal antibody treatment Leqembi (lecanemab) has received approval from the Ministry of ...
Posted by Michael Wonder on 28 May 2024
Fresenius announces FDA acceptance for review of denosumab biosimilar application
27 May 2024 - Fresenius announced today that the US FDA has accepted for review the company’s biologics license application ...
Posted by Michael Wonder on 28 May 2024
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma
27 May 2024 - FDA priority review granted based on positive results from IMROZ Phase 3 study. ...