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 11 Jun 2024
Trifluridine with tipiracil hydrochloride in combination with bevacizumab for the treatment of patients with metastatic colorectal cancer after two systemic treatments
6 June 2024 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...
Posted by Michael Wonder on 10 Jun 2024
FDA grants fast track designation to GCBP and Novel Pharma's GC1130A
10 June 2024 - GC Biopharma and Novel Pharma have announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 10 Jun 2024
SMC - June 2024 decisions
10 June 2024 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 10 Jun 2024
European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK positive early-stage lung cance
10 June 2024 - Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK ...
Posted by Michael Wonder on 10 Jun 2024
FDA approves Almirall’s Klisyri (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2
10 June 2024 - Original FDA approval (December 2020) now extended to the use of Klisyri on larger areas of the ...
Posted by Michael Wonder on 10 Jun 2024
Tagrisso granted priority review in the US for patients with unresectable, stage III EGFR mutated lung cancer
10 June 2024 - Decision based on LAURA Phase 3 trial results which extended median progression-free survival by more than ...
Posted by Michael Wonder on 10 Jun 2024
FDA accepts filing of Leqembi (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer's Disease
8 June 2024 - Eisai announced today that that the US FDA has accepted Eisai's supplemental biologics license application for ...
Posted by Michael Wonder on 10 Jun 2024
SpliSense receives FDA fast track designation for SPL84 for the treatment of cystic fibrosis
29 May 2024 - SpliSense today announced that the US FDA has granted fast track designation to SPL84 for cystic ...
Posted by Michael Wonder on 09 Jun 2024
US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus vaccine for adults aged 50-59 at increased risk
7 June 2024 - Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of ...
Posted by Michael Wonder on 08 Jun 2024
Danicopan in combination with ravulizumab or eculizumab for the treatment of patients with paroxysmal nocturnal haemoglobinuria
29 May 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 08 Jun 2024
Moderna files FDA application for the JN.1 targeting COVID-19 vaccine
7 June 2024 - Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as ...
Posted by Michael Wonder on 08 Jun 2024
Updated COVID-19 vaccines for use in the United States beginning in fall 2024
7 June 2024 - The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 5 June 2024 to ...
Posted by Michael Wonder on 07 Jun 2024
FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anaemia
6 June 2024 - Today, the FDA approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- ...
Posted by Michael Wonder on 06 Jun 2024
Ivonescimab in combination with chemotherapy approved in China by NMPA for 2L+ EGFRm NSCLC based on HARMONi-A clinical trial: positive trend observed in overall survival towards ivonescimab plus chemotherapy
31 May 2024 - Separate and distinct from HARMONi-2 announcement, HARMONi-A showed clinically meaningful and statistically significant benefit: progression-free survival hazard ...
Posted by Michael Wonder on 06 Jun 2024
BlueRock Therapeutics receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease cell therapy candidate bemdaneprocel
31 May 2024 - Regenerative Medicine Advanced Therapy designation follows phase I clinical trial results demonstrating that bemdaneprocel is well tolerated ...