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 01 May 2021
Legend Biotech announces submission of European marketing authorisation application for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
30 April 2021 - Submission follows accelerated assessment granted by the Committee for Medicinal Products for Human Use of the European ...
Posted by Michael Wonder on 01 May 2021
New Zealand Pharmaceutical Schedule - 1 May 2021 update
1 May 2021 - The May 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 30 Apr 2021
FDA approves higher dosage of naloxone nasal spray to treat opioid overdose
30 April 2021 - The U.S. FDA announced today the approval of a higher dose naloxone hydrochloride nasal spray product to ...
Posted by Michael Wonder on 30 Apr 2021
FDA approves treatment for chronic kidney disease
30 April 2021 - Approval is first to cover many causes of disease. ...
Posted by Michael Wonder on 30 Apr 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for patients with muscle-invasive urothelial carcinoma
30 April 2021 - Application based on Phase 3 CheckMate-274 trial, in which Opdivo nearly doubled disease-free survival compared to placebo. ...
Posted by Michael Wonder on 30 Apr 2021
Americans paid two to four times as much for some drugs as in three other countries
28 April 2021 - Amid national angst over the cost of prescription drugs, a new analysis finds that U.S. consumers ...
Posted by Michael Wonder on 30 Apr 2021
Cancer expert to head review into efficient and equitable access to chemotherapy medicines
1 May 2021 - Renowned cancer expert Professor Sanchia Aranda AM will head an Australian Government review aimed at making ...
Posted by Michael Wonder on 30 Apr 2021
Update on U.S. FDA review of LEO Pharma’s biologics license application for tralokinumab for the treatment of adults with moderate to severe atopic dermatitis
29 April 2021 - FDA has requested additional data relating to a device component of tralokinumab. ...
Posted by Michael Wonder on 30 Apr 2021
Bristol Myers Squibb statement on FDA Advisory Committee meeting on Opdivo post sorafenib hepatocellular carcinoma U.S. indication
29 April 2021 - As part of its industry-wide review of accelerated approvals in oncology without confirmatory benefit, the U.S ...
Posted by Michael Wonder on 30 Apr 2021
AstraZeneca struggles with data needed for COVID-19 vaccine’s approval
29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout ...
Posted by Michael Wonder on 30 Apr 2021
Ilaris receives Health Canada approval as first of its kind treatment for rare, inflammatory disorder, adult-onset Still's disease
29 April 2021 - The approval of Ilaris (canakinumab) in the treatment of adult-onset Still's disease brings hope for Canadians living ...
Posted by Michael Wonder on 30 Apr 2021
Xeris Pharmaceuticals receives U.K. MHRA approval of Ogluo (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents and children aged 2 years and over with diabetes mellitus
29 April 2021 - Xeris Pharmaceuticals today announced that the United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA) has approved ...
Posted by Michael Wonder on 30 Apr 2021
Historic PBS listing for Australians with a rare epilepsy condition
30 April 2021 - In an historic first, Australians living with a rare form of epilepsy will have access to a ...
Posted by Michael Wonder on 30 Apr 2021
Cerapedics announces FDA breakthrough device designation granted for P-15L bone graft for the treatment of degenerative disc disease
29 April 2021 - P-15L bone graft is currently being studied in the Company's ASPIRE IDE clinical trial. ...
Posted by Michael Wonder on 29 Apr 2021
FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for previously untreated metastatic bladder cancer
28 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favour of ...