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 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 ...
Posted by Michael Wonder on 21 Feb 2026
US FDA accepts Teva’s new drug application for olanzapine extended release injectable suspension (TEV-'749) for the once monthly treatment of schizophrenia in adults
20 February 2026 - Teva Pharmaceuticals and Medincell announced today that the US FDA has accepted its new drug application (NDA) ...
Posted by Michael Wonder on 21 Feb 2026
Canada's public drug plans shouldn't cover new Alzheimer's drug, agency says
19 February 2026 - Lecanemab, also known as Leqembi, is approved to treat mild cognitive impairment, early Alzheimer's. ...
Posted by Michael Wonder on 21 Feb 2026
Vanda Pharmaceuticals announces FDA approval of Bysanti (milsaperidone) for the treatment of bipolar I disorder and schizophrenia - a new chemical entity opening new horizons in psychiatric innovation
20 February 2026 - - Vanda Pharmaceuticals today announced that the US FDA has approved Bysanti (milsaperidone) tablets, a first ...
Posted by Michael Wonder on 21 Feb 2026
FDA accepts new drug application for Roche’s giredestrant in ESR1 mutated, ER positive advanced breast cancer
20 February 2026 - Roche announced today that the US FDA has accepted the company’s new drug application for giredestrant, an ...
Posted by Michael Wonder on 21 Feb 2026
MHRA approves zanidatamab (Ziihera) for the treatment of biliary tract cancer
19 February 2026 - Zanidatamab is used when the cancer cannot be removed by surgery and has spread to nearby tissues ...
Posted by Michael Wonder on 21 Feb 2026
FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukaemia or small lymphocytic lymphoma
20 February 2026 - On 19 February 2026, the FDA approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax ...