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RSS FeedPosted by Michael Wonder on 06 May 2025
Health Canada has granted approval for Tzield, the first and only disease-modifying therapy in auto-immune type 1 diabetes in Canada
5 May 2025 - Tzield is demonstrated to delay by a median of 2 years the onset of Stage 3 type ...
Posted by Michael Wonder on 06 May 2025
Calquence plus chemoimmunotherapy approved in the EU as first and only BTK inhibitor for first-line mantle cell lymphoma
6 May 2025 - Approval based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 06 May 2025
Rezolute receives breakthrough therapy designation from FDA for ersodetug in the treatment of hypoglycaemia due to tumour hyperinsulinism
5 May 2025 - Registrational study in patients with tumour hyperinsulinism expected to commence mid-year. ...
Posted by Michael Wonder on 06 May 2025
Ichnos Glenmark Innovation receives US FDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma
5 May 2025 - IGI, today announced that the US FDA has granted fast track designation for ISB 2001. ...
Posted by Michael Wonder on 06 May 2025
Alterity Therapeutics granted US FDA fast track designation for ATH434 to treat multiple system atrophy
5 May 2025 - Alterity Therapeutics today announced that the US FDA has granted fast track designation for ATH434 for the ...
Posted by Michael Wonder on 06 May 2025
Teva and Alvotech announce FDA approval of interchangeability for Selarsdi (ustekinumab-aekn) with Stelara (ustekinumab)
5 May 2025 - The US FDA has approved Selarsdi (ustekinumab-aekn) as interchangeable with the reference biologic Stelara (ustekinumab) in all ...
Posted by Michael Wonder on 04 May 2025
Government lists life-changing epilepsy drug fenfluramine on PBS
4 May 2025 - For the Sutton family, finding a drug that controlled four-year-old daughter Layla’s rare form of epilepsy was ...
Posted by Michael Wonder on 04 May 2025
Health Canada accepts semaglutide 2.4 mg, a GLP-1 receptor agonist treatment for MASH, as a supplemental new drug submission under the priority review policy
2 May 2025 - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the priority review policy, ...
Posted by Michael Wonder on 03 May 2025
FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity
2 May 2025 - The FDA filing is based on the results of the Phase 3 OASIS 4 trial that evaluated ...
Posted by Michael Wonder on 02 May 2025
DoH publishes revised agenda for the May 2025 PBAC meeting
2 May 2025 - The agenda for the May 2025 PBAC meeting has been updated. ...
Posted by Michael Wonder on 02 May 2025
Satsuma Pharmaceuticals announces US FDA approval for Atzumi (dihydroergotamine) nasal powder for the acute treatment of migraine
30 April 2025 - Atzumi is the first and only product utilising the SMART (Simple MucoAdhesive Release Technology) platform which combines ...
Posted by Michael Wonder on 02 May 2025
Cytokinetics announces new PDUFA date for aficamten in obstructive hypertrophic cardiomyopathy
1 May 2025 - Cytokinetics today announced that the US FDA has extended the PDUFA action date for the New Drug ...
Posted by Michael Wonder on 02 May 2025
Pfizer’s ALK lung cancer drug Lorviqua lands first-line reimbursement in Korea
2 May 2025 - Pfizer Korea has secured reimbursement for Lorviqua (lorlatinib) as a first-line treatment for ALK-positive metastatic non-small ...
Posted by Michael Wonder on 01 May 2025
FDA grants OKYO Pharma fast track designation to urcosimod for neuropathic corneal pain
1 May 2025 - OKYO Pharma announces that the US FDA has granted fast track designation to urcosimod for the treatment ...
Posted by Michael Wonder on 01 May 2025
Up to 1,000 women a year could benefit from new at-home treatment for endometriosis
1 May 2025 - Our final draft guidance recommends linzagolix (Yselty, Theramex) with hormonal add-back therapy for adults of reproductive age ...