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 07 Apr 2023
Update on Imbruvica (ibrutinib) US accelerated approvals for mantle cell lymphoma and marginal zone lymphoma indications
6 April 2023 - AbbVie announced today the intent to voluntarily withdraw, in the US, accelerated Imbruvica (ibrutinib) approvals for ...
Posted by Michael Wonder on 07 Apr 2023
FDA Commissioner and Chief Scientist announce decision to withdraw approval of Makena
6 April 2023 - Today, the US FDA announced the final decision to withdraw approval of Makena—a drug that had been ...
Posted by Michael Wonder on 06 Apr 2023
Enanta Pharmaceuticals receives FDA fast track designation for EDP-323, its oral, L-protein inhibitor in development for the treatment of respiratory syncytial virus
6 April 2023 - Enanta Pharmaceuticals today announced that the US FDA has granted fast track designation for EDP-323, Enanta’s ...
Posted by Michael Wonder on 06 Apr 2023
Trastuzumab deruxtecan for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastro-oesophageal junction cancer after anti-HER2 treatment
6 April 2023 - NICE is unable to make a recommendation on the use of trastuzumab deruxtecan (Enhertu) for the treatment ...
Posted by Michael Wonder on 06 Apr 2023
AstraZeneca vaccine discontinued by Federal Government
5 April 2023 - One of the first COVID-19 jabs offered to Australians has been quietly discontinued, the Federal Government has ...
Posted by Michael Wonder on 06 Apr 2023
Public summary documents – December 2022 PBAC meeting
6 April 2023 - The public summary documents (positive recommendations and subsequent decisions not to recommend) from the December 2022 PBAC ...
Posted by Michael Wonder on 06 Apr 2023
Life changing cystic fibrosis treatment now available to children 6 years and above
6 April 2023 - From 1 May 2023, children aged 6 to 11 with cystic fibrosis will have access to ...
Posted by Michael Wonder on 06 Apr 2023
Mirum submits for European approval of Livmarli in progressive familial intrahepatic cholestasis
5 April 2023 - Application based on statistically significant and clinically meaningful improvements in serum bile acids, pruritus, bilirubin, and growth ...
Posted by Michael Wonder on 05 Apr 2023
PHARMAC shares next steps in reviewing rule 8.1b
5 April 2023 - PHARMAC’s consultation on rule 8.1b of the Pharmaceutical Schedule has now closed. ...
Posted by Michael Wonder on 05 Apr 2023
Caribou Biosciences announces FDA granted fast track designation to CB-011, an allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma
4 April 2023 - CaMMouflage Phase 1 trial for CB-011 enrolling patients with relapsed or refractory multiple myeloma at dose level ...
Posted by Michael Wonder on 05 Apr 2023
Verismo Therapeutics secures fast track designation from the US FDA for SynKIR-110
5 April 2023 - SynKIR-110 addresses gaps in treatment options for those with malignant pleural mesothelioma, a rare and aggressive ...
Posted by Michael Wonder on 05 Apr 2023
HHS finalises rule to strengthen Medicare, improve access to affordable prescription drug coverage and hold private insurance companies accountable to delivering quality health care for America’s seniors and people with disabilities
5 April 2023 - Thanks to President Biden’s new law to lower prescription drug costs, the final rule will also ...
Posted by Michael Wonder on 05 Apr 2023
‘An absolute game changer’: children under 12 to receive life saving drug
6 April 2023 - Hundreds of children with cystic fibrosis will have subsidised access to the life-changing medication Trikafta from ...
Posted by Michael Wonder on 05 Apr 2023
MHRA grants ADvantage Therapeutics Innovative Licensing and Access Pathway designation for novel lead product AD04 for Phase 2b trial in Alzheimer’s sisease
5 April 2023 - ADvantage Therapeutics today announced that the MHRA has granted the Company’s lead compound AD04 an Innovation Passport ...
Posted by Michael Wonder on 05 Apr 2023
Ipsen reacts to NICE’s Cabometyx verdict
5 April 2023 - Company disappointed by institute’s failure to recommend thyroid cancer therapy for specific patient group ...