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 26 Mar 2026
Apotex expands Canadian ophthalmology portfolio with Health Canada's approval of Clobivis (clobetasol propionate ophthalmic suspension, 0.05%)
25 March 2026 - Apotex today announced that Health Canada has approved Clobivis (clobetasol propionate ophthalmic suspension, 0.05%), indicated for ...
Posted by Michael Wonder on 25 Mar 2026
ICER launches program to accelerate the consideration of value into drug development programs
25 March 2026 - ICER will leverage its health technology assessment expertise to encourage better evidence development in clinical trial ...
Posted by Michael Wonder on 25 Mar 2026
Triana Biomedicines’ TRI-611 granted US FDA fast track designation for treatment of ALK positive non-small cell lung cancer
25 March 2026 - Triana Biomedicines today announced that the US FDA granted fast track designation for TRI-611, an investigational molecular ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves drug to treat neurologic manifestations of Hunter syndrome
25 March 2026 - The US FDA approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (mucopolysaccharidosis type II ...
Posted by Michael Wonder on 25 Mar 2026
Anavex Life Sciences provides update on regulatory review in the EU for blarcamesine to treat early Alzheimer’s disease
25 March 2026 - Anavex Life Sciences today announced that it has withdrawn its application for the marketing authorisation of ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
25 March 2026 - Today, the FDA approved relacorilant (Lifyorli, Corcept Therapeutics), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel ...
Posted by Michael Wonder on 25 Mar 2026
Agenda for the July 2026 PBAC meeting (25 March 2026)
25 March 2026 - The agenda for the July 2026 PBAC meeting is now available. ...
Posted by Michael Wonder on 25 Mar 2026
New public listings for Canadians living with pulmonary arterial hypertension
24 March 2026 - Merck announced today that British Columbia, Non-Insured Health Benefits (NIHB), Nova Scotia, Quebec and Veterans Affairs Canada ...
Posted by Michael Wonder on 24 Mar 2026
Dupixent (dupilumab) approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid
24 March 2026 - Bullous pemphigoid is the seventh approved indication for Dupixent in Japan ...
Posted by Michael Wonder on 23 Mar 2026
Ionis announces zilganersen new drug application for Alexander disease accepted by FDA for priority review
23 March 2026 - Ionis Pharmaceuticals today announced that the US FDA has accepted for priority review the new drug application ...
Posted by Michael Wonder on 23 Mar 2026
EMA publishes agenda for 23-26 March 2026 CHMP meeting
23 March 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 23 Mar 2026
Enhertu now available in Japan as first antibody drug conjugate for the second-line treatment of patients with HER2 positive metastatic gastric cancer
23 March 2026 - Based on DESTINY-Gastric04 Phase 3 trial results that showed Enhertu demonstrated statistically significant and clinically meaningful ...
Posted by Michael Wonder on 23 Mar 2026
Enhertu approved in Japan as first tumour agnostic HER2 directed medicine for previously treated patients with HER2 positive metastatic solid tumours
23 March 2026 - Based on four Phase 2 trials where Enhertu demonstrated clinically meaningful responses across a broad range ...
Posted by Michael Wonder on 22 Mar 2026
IntraBio announces submission of supplemental new drug application for levacetylleucine for ataxia-telangiectasia
20 March 2026 - IntraBio today announced the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 21 Mar 2026
Toward greater transparency at the FDA - now is the time to act
18 March 2026 - The US FDA has generally sought to uphold the highest standards of scientific rigour in its regulation ...