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 12 Jan 2026
Encoded Therapeutics announces US FDA breakthrough therapy designation granted to ETX101 for the treatment of Dravet syndrome
12 January 2026 - Encoded Therapeutics today announced that the US FDA has granted breakthrough therapy designation to ETX101 for the ...
Posted by Michael Wonder on 12 Jan 2026
FDA accepts new drug application for pimicotinib for the treatment of tenosynovial giant cell tumoir
12 January 2026 - Merck announced today that the US FDA has accepted the company’s new drug application for pimicotinib as ...
Posted by Michael Wonder on 12 Jan 2026
FDA approves first treatment for children with Menkes disease
12 January 2026 - The US FDA today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease ...
Posted by Michael Wonder on 12 Jan 2026
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
12 January 2026 - Atara Biotherapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 12 Jan 2026
PHARMAC funds treatment for rare disorders
12 January 2026 - PHARMAC will fund nitisinone for people with the rare disorders tyrosinaemia type 1 and alkaptonuria from ...
Posted by Michael Wonder on 11 Jan 2026
Health Minister ‘committed’ to listing weight loss drugs on PBS
9 January 2026 - ‘It’s an equity issue as well as a health issue from my perspective.’ ...
Posted by Michael Wonder on 11 Jan 2026
Aquestive Therapeutics announces regulatory development for Anaphylm (dibutepinephrine) sublingual film
9 January 2026 - Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at ...
Posted by Michael Wonder on 11 Jan 2026
Camurus announces FDA acceptance of NDA resubmission for Oclaiz for the treatment of acromegaly
9 January 2026 - Camurus today announced that the US FDA has accepted for review the company's resubmission of the new ...
Posted by Michael Wonder on 11 Jan 2026
Stimulant meds for ADHD now fastest growing drug on PBS
11 January 2026 - A stimulant drug used to treat ADHD has become the fastest-growing script on the PBS, prompting ...
Posted by Michael Wonder on 09 Jan 2026
Agenda for the March 2026 PBAC meeting (9 January 2026)
9 January 2026 - The Department of Health has published an updated agenda for the March 2026 PBAC agenda (version ...
Posted by Michael Wonder on 09 Jan 2026
GSK’s Shingrix (recombinant zoster vaccine) pre-filled syringe presentation approved by the European Commission
7 January 2026 - New presentation will begin rolling out across EU countries in 2026. ...
Posted by Michael Wonder on 09 Jan 2026
Wockhardt files marketing authorisation application for WCK 5222 with EMA
7 January 2026 - Wockhardt has successfully filed a marketing authorisation application with the EMA for its novel antibiotic, WCK ...
Posted by Michael Wonder on 09 Jan 2026
Annexon submits tanruprubart marketing authorisation application to the EMA for Guillain-Barré syndrome
8 January 2026 - BLA submission with US/European data from FORWARD trial planned in 2026 ...
Posted by Michael Wonder on 09 Jan 2026
VectorY Therapeutics receives FDA fast track designation for VTx-002, a first in class vectorised antibody targeting underlying disease biology in ALS
8 January 2026 - VectorY Therapeutics announced today that the US FDA has granted fast track designation for VTx-002, a first-in-class ...
Posted by Michael Wonder on 09 Jan 2026
Revolution Medicines announces FDA breakthrough therapy designation for zoldonrasib
8 January 2026 - First breakthrough therapy designation for an investigational drug specifically targeting KRAS G12D mutation in non-small cell lung ...