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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 25 Feb 2026
Larimar Therapeutics announces FDA breakthrough therapy designation for nomlabofusp in FA and reiterates planned BLA submission in June 2026
24 February 2026 - Larimar Therapeutics today announced the US FDA has granted breakthrough therapy designation to nomlabofusp, a frataxin protein ...
Posted by Michael Wonder on 25 Feb 2026
Johnson & Johnson seeks FDA approval of Imavvy (nipocalimab-aahu) as the first-ever FDA approved treatment for warm autoimmune hemolytic anemia
24 February 2026 - Data from the pivotal ENERGY trial showed Imavvy produced a rapid and durable hemoglobin response in wAIHA. ...
Posted by Michael Wonder on 24 Feb 2026
Wegovy and Mounjaro for weight loss not funded
24 February 2026 - Medsafe has recently approved two new medicines as suitable to support weight management. ...
Posted by Michael Wonder on 24 Feb 2026
First treatment for vitiligo recommended by NICE for NHS use, bringing hope to over 80,000 people
24 February 2026 - For the first time, NICE has recommended a medicine that effectively treats the underlying cause of devastating ...
Posted by Michael Wonder on 24 Feb 2026
Novo Nordisk announces significant reduction in US list price for Wegovy, Ozempic and Rybelsus (semaglutide medicines), building on continued efforts to expand access
24 February 2026 - Today, Novo Nordisk announced that, effective 1 January 2027, the company will lower the list price, ...
Posted by Michael Wonder on 24 Feb 2026
US FDA has granted accelerated approval of Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in patients 2 years and older with arginase 1 deficiency
23 February 2026 - Immedica Pharma today announced that the US FDA has granted accelerated approval of Loargys (pegzilarginase-nbln), an ...
Posted by Michael Wonder on 24 Feb 2026
FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation
24 February 2026 - Today, the FDA granted traditional approval to encorafenib (Braftovi, Array BioPharma, a subsidiary of Pfizer) in ...
Posted by Michael Wonder on 24 Feb 2026
Dupixent (dupilumab) approved in the US as the first and only medicine for allergic fungal rhinosinusitis
24 February 2026 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has approved Dupixent (dupilumab) for the treatment ...
Posted by Michael Wonder on 24 Feb 2026
Brensocatib licensed as the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis in patients 12 years and older
23 February 2026 - The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for the medicine brensocatib ...
Posted by Michael Wonder on 24 Feb 2026
Ultragenyx announces US FDA acceptance and priority review of the biologics license application for DTX401 AAV gene therapy for glycogen storage disease type Ia
23 February 2026 - Ultragenyx today announced the US FDA has accepted for review the biologics license application seeking approval of ...
Posted by Michael Wonder on 24 Feb 2026
PHARMAC proposes to widen access to two medicines for people with melanoma
24 February 2026 - PHARMAC is proposing to widen access to two medicines used to treat melanoma, giving people another ...
Posted by Michael Wonder on 24 Feb 2026
FDA launches framework for accelerating development of individualised therapies for ultra-rare diseases
23 February 2026 - The U.S. FDA today issued draft guidance for sponsors seeking approval for targeted individualised therapies by ...
Posted by Michael Wonder on 24 Feb 2026
Artios receives US FDA fast track designation for DNA polymerase theta inhibitor ART6043 for treatment of gBRCA-mutated HER2 negative breast cancer
23 February 2026 - Artios Pharma today announced that the US FDA granted fast track designation to its potentially first ...
Posted by Michael Wonder on 24 Feb 2026
Armata Pharmaceuticals receives FDA Qualified Infectious Disease Product designation for AP-SA02
23 February 2026 - Armata Pharmaceuticals today announced that the US FDA has granted AP-SA02, the Company's Staphylococcus aureus ("S. aureus") ...
Posted by Michael Wonder on 23 Feb 2026
Tessera Therapeutics receives US FDA fast track and orphan drug designations for its lead in vivo gene editing program TSRA-196 for the treatment of adults with AATD
23 February 2026 - Tessera Therapeutics today announced that the US FDA has granted fast track and orphan drug designations to ...