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 30 Nov 2021
Lynparza granted priority review in the US for BRCA mutated HER2 negative high risk early breast cancer
30 November 2021 - First medicine targeting BRCA mutations to show clinical benefit in adjuvant setting. ...
Posted by Michael Wonder on 30 Nov 2021
Caldolor now FDA approved for pre-operative administration
29 November 2021 - Dosed prior to surgery, Caldolor demonstrated significant reduction in pain intensity. ...
Posted by Michael Wonder on 30 Nov 2021
Updated 2021 – 22 cost recovery implementation statement
30 November 2021 - The 2021-22 Pharmaceutical Benefits Scheme and National Immunisation Plan Cost Recovery Implementation Statement has been updated ...
Posted by Michael Wonder on 29 Nov 2021
Bristol Myers Squibb’s applications for deucravacitinib for the treatment of moderate to severe plaque psoriasis accepted by U.S. Food and Drug Administration and validated by European Medicines Agency
29 November 2021 - Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy ...
Posted by Michael Wonder on 29 Nov 2021
Biosimilar industry vets critique Biden's drug pricing reforms
29 November 2021 - Specialty tiers for biosimilars and reforms that address the proliferation of poor quality patents would help ...
Posted by Michael Wonder on 29 Nov 2021
TGA approves Bayer's Verquvo
29 November 2021 - Verquvo has been approved under the Black Triangle Scheme. ...
Posted by Michael Wonder on 29 Nov 2021
FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products
29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...
Posted by Michael Wonder on 29 Nov 2021
FDA approves new imaging drug to help identify ovarian cancer lesions
29 November 2021 - The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist ...
Posted by Michael Wonder on 29 Nov 2021
TGA approves new medicines for patients with graft versus host disease
26 November 2021 - Rholistiq is Kadmon's first product to be approved in Australia. ...
Posted by Michael Wonder on 29 Nov 2021
NICE publishes draft guidance on new medicine for osteoporosis
25 November 2021 - The Department of Health and Social Care has asked NICE to produce guidance on using romosozumab in ...
Posted by Michael Wonder on 29 Nov 2021
U.S. Food and Drug Administration approves Longeveron’s Lomecel-B for rare paediatric disease designation to treat life-threatening infant heart condition
18 November 2021 - Phase 2 clinical trial underway for hypoplastic left heart syndrome, which affects approximately 1,000 babies per ...
Posted by Michael Wonder on 29 Nov 2021
Mayne Pharma and Mithra announce TGA approval of Nextstellis oral contraceptive
29 November 2021 - Mayne Pharma and Mithra Pharmaceuticals are very pleased to announce the TGA has approved the novel combined ...
Posted by Michael Wonder on 29 Nov 2021
Fennec Pharmaceuticals expects to receive complete response letter from the FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic solid tumours
29 November 2021 - FDA pre-approval inspection identified deficiencies with the facility of the drug product manufacturer, which require resolution prior ...
Posted by Michael Wonder on 28 Nov 2021
Anti-cancer agent Herceptin approved for additional indication of salivary gland cancer
25 November 2021 - Herceptin has been approved as the first drug for salivary gland cancer, for which there is no ...
Posted by Michael Wonder on 28 Nov 2021
New treatment for Australians with leukaemia
28 November 2021 - From 1 December 2021, Australians with acute myeloid leukaemia will have access to a new treatment option ...