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RSS FeedPosted 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1 May 2025 - Our final draft guidance recommends linzagolix (Yselty, Theramex) with hormonal add-back therapy for adults of reproductive age ...
Posted by Michael Wonder on 01 May 2025
MHRA authorises cancer treatment variation with an administration time of 3–5 minutes
30 April 2025 - The MHRA has today approved a new under-the-skin injection version of the cancer therapy, nivolumab (Opdivo), ...
Posted by Michael Wonder on 01 May 2025
AstraZeneca Korea reapplies for Lynparza reimbursement in prostate cancer
22 April 2025 - AstraZeneca Korea has recently reapplied for health insurance coverage for its PARP inhibitor Lynparza (olaparib) for ...
Posted by Michael Wonder on 30 Apr 2025
Q32 Bio announces FDA fast track designation granted to bempikibart (ADX-914) for the treatment of alopecia areata
30 April 2025 - Q32 Bio today announced that the US FDA has granted fast track designation to Q32 Bio's bempikibart ...
Posted by Michael Wonder on 30 Apr 2025
Johnson & Johnson receives FDA approval for Imaavy (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis
30 April 2025 - First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and paediatric generalised myasthenia gravis. ...
Posted by Michael Wonder on 30 Apr 2025
SMC - April 2025 decisions
7 April 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 29 Apr 2025
BioInvent receives FDA fast track designation for BI-1808 for the treatment of cutaneous T-cell lymphoma
29 April 2025 - BioInvent today announces that the US FDA has granted fast track designation to BI-1808, a first-in-class ...
Posted by Michael Wonder on 29 Apr 2025
Incyclix Bio granted US FDA fast track designation for INX-315 to treat CCNE1-amplified platinum-resistant/refractory ovarian cancer
29 April 2025 - Incyclix Bio today announced that the US FDA has granted fast track designation for INX-315 for ...