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 05 Jan 2026
Protara Therapeutics receives both FDA breakthrough therapy and fast track designations for TARA-002 in paediatric patients with lymphatic malformations
5 January 2026 - Protara Therapeutics today announced that the US FDA has granted both breakthrough therapy and fast track designations ...
Posted by Michael Wonder on 05 Jan 2026
MapLight Therapeutics receives fast track designation for ML-007C-MA for Alzheimer’s disease psychosis
5 January 2026 - MapLight Therapeutics today announced that the US FDA has granted fast track designation to ML-007C-MA, an investigational ...
Posted by Michael Wonder on 05 Jan 2026
Takeda and Protagonist announce submission of new drug application for rusfertide for treatment of polycythemia vera
5 January 2026 - NDA includes 52 week data from Phase 3 VERIFY study, which met the primary and all four ...
Posted by Michael Wonder on 05 Jan 2026
Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes
5 January 2026 - The US FDA has accepted for priority review the supplemental biologic license application for Tzield (teplizumab-mzwv) to ...
Posted by Michael Wonder on 05 Jan 2026
SMC - December 2025 decisions
8 December 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 04 Jan 2026
Bayer Korea's Eylea pre-filled syringe 8 mg to receive health insurance coverage
30 December 2025 - Bayer Korea announced that its Eylea pre-filled syringe 8 mg will be covered by health insurance ...
Posted by Michael Wonder on 04 Jan 2026
GC Biopharma’s Livmarli listed for national health insurance coverage for Alagille syndrome
2 January 2026 - GC Biopharma said Livmarli (maralixibat chloride), a treatment for Alagille syndrome, has been officially listed on ...
Posted by Michael Wonder on 03 Jan 2026
Family’s desperate plea as lifesaving cancer drug delayed by PBS bureaucracy
3 January 2026 - A $32,000 cancer treatment has given one man hope of seeing his children grow up, but PBS ...
Posted by Michael Wonder on 02 Jan 2026
New year relief with cheaper medicines, 1800MEDICARE and more mental health support
1 January 2025 - The Albanese Labor Government is delivering cheaper medicines, 1800MEDICARE and more mental health support for Australians this ...
Posted by Michael Wonder on 02 Jan 2026
New Zealand Pharmaceutical Schedule - 1 January 2026
1 January 2026 - The January 2026 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 02 Jan 2026
Savara resubmits the biologics license application to the US FDA for Molbreevi for the potential treatment of auto-immune pulmonary alveolar proteinosis
22 December 2025 - Savara announced today that it has resubmitted the Molbreevi BLA to the FDA, with Fujifilm as ...
Posted by Michael Wonder on 01 Jan 2026
Corcept receives complete response letter for relacorilant as a treatment for patients with hypercortisolism
31 December 2025 - Corcept Therapeutics today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 01 Jan 2026
Outlook Therapeutics provides regulatory update on US FDA review of ONS-5010/Lytenava (bevacizumab-vikg) for the treatment of wet AMD (December 2025)
31 December 2025 - FDA issues complete response letter for resubmitted ONS-5010 BLA. ...
Posted by Michael Wonder on 01 Jan 2026
Axsome Therapeutics announces FDA acceptance and priority review of supplemental new drug application for AXS-05 for the treatment of Alzheimer’s disease agitation
31 December 2025 - FDA grants AXS-05 priority review designation and sets PDUFA action goal date of 30 April 2026. ...
Posted by Michael Wonder on 31 Dec 2025
Schedule of Pharmaceutical Benefits - 1 January 2026
1 January 2026 - The January 2026 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...