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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 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23 February 2026 - The U.S. FDA today issued draft guidance for sponsors seeking approval for targeted individualised therapies by ...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 ...
Posted by Michael Wonder on 23 Feb 2026
US FDA grants Reunion Neuroscience’s luvesilocin (RE104) breakthrough therapy designation status
23 February 2026 - Reunion Neuroscience today announced that the US FDA has granted breakthrough therapy designation to luvesilocin (formerly ...
Posted by Michael Wonder on 23 Feb 2026
Beren Therapeutics announces FDA acceptance of its new drug application for adrabetadex in infantile-onset Niemann-Pick disease type C
23 February 2026 - Beren Therapeutics today announced that the US FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 23 Feb 2026
Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen
23 February 2026 - Eli Lilly today announced the US FDA approved a label expansion for Zepbound (tirzepatide) to include the ...
Posted by Michael Wonder on 23 Feb 2026
EMA publishes agenda for 23-26 February 2026 CHMP meeting
23 February 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 23 Feb 2026
Sandoz confirms European Commission approval for Ranluspec (ranibizumab)
23 February 2026 - Launch expected second half of 2026; potential to expand access to life-changing treatment option for European patients. ...
Posted by Michael Wonder on 21 Feb 2026
Do children get priority in Australia's drug funding decisions?
20 February 2026 - In Australia, the PBAC recommends which medicines should be subsidised through the PBS. ...
Posted by Michael Wonder on 21 Feb 2026
Aumorlertinib mesylate tablets approved in the EU as monotherapy
20 February 2026 - Hansoh Pharmaceutical is pleased to announce that, on 12 February 2026, aumolertinib mesylate tablets have been ...