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RSS FeedPosted by Michael Wonder on 01 Nov 2024
10,000 New Zealanders set to benefit from PHARMAC budget increase
1 November 2024 - Thirteen new medicines funded from today will benefit thousands of New Zealanders with various health conditions ...
Posted by Michael Wonder on 31 Oct 2024
Verastem Oncology completes rolling NDA submission to the FDA for avutometinib plus defactinib as a treatment for recurrent KRAS mutant low grade serous ovarian cancer
31 October 2024 - Company seeking accelerated approval and priority review of its new drug application submission in patients with KRAS ...
Posted by Michael Wonder on 31 Oct 2024
Sugemalimab approved to treat adult patients with non-small cell lung cancer
30 October 2024 - The MHRA has today approved sugemalimab (Eqjubi) to treat adult patients with non-small cell lung cancer. ...
Posted by Michael Wonder on 31 Oct 2024
Foresee Pharmaceuticals announces submission of the NDA to the US FDA for the 3 month version of Camcevi for the treatment of advanced prostate cancer
30 October 2024 - Foresee Pharmaceuticals announced today that it has submitted a 505(b)(2) new drug application for the 3 month ...
Posted by Michael Wonder on 30 Oct 2024
Osimertinib mesylate in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with advanced EGFR mutation positive non-small-cell lung cancer
30 October 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 30 Oct 2024
Lilly Canada and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Verzenio (abemaciclib) in expanded early breast cancer indication
29 October 2024 - Eli Lilly Canada is pleased to announce that it received a positive Canada's Drug Agency (CDA-AMC, formally ...
Posted by Michael Wonder on 29 Oct 2024
Allogene Therapeutics receives FDA regenerative medicine advanced therapy designation for ALLO-316, an AlloCAR T investigational product for adult patients with advanced or metastatic renal cell carcinoma
29 October 2024 - ALLO-316 was previously granted fast track designation in March 2022 by the US FDA. ...
Posted by Michael Wonder on 29 Oct 2024
FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukaemia
29 October 2024 - Today, the FDA granted accelerated approval to asciminib (Scemblix, Novartis) for adult patients with newly diagnosed ...
Posted by Michael Wonder on 29 Oct 2024
People with a rare form of blood cancer are set to benefit after NICE recommends new targeted therapy
29 October 2024 - Hundreds of people with a rare form of blood cancer could be set to benefit after NICE ...
Posted by Michael Wonder on 24 Oct 2024
Merck’s Keytruda (pembrolizumab) receives 30th approval from European Commission with two new indications in gynaecologic cancers
24 October 2024 - Keytruda plus chemotherapy is the first approval in the EU for an anti-PD-1 therapy combined with chemotherapy ...
Posted by Michael Wonder on 24 Oct 2024
Quizartinib dihydrochloride for the induction, consolidation and maintenance treatment of adults with newly diagnosed FLT3-ITD positive acute myeloid leukaemia
23 October 2024 - NICE has published final evidence-based recommendations on the use of quizartinib dihydrochloride (Vanflyta) for the induction, ...
Posted by Michael Wonder on 24 Oct 2024
HiberCell receives FDA fast track designation for HC-7366 for the treatment of relapsed or refractory acute myeloid leukaemia
23 October 2024 - HiberCell is pleased to announce that the US FDA has granted fast track designation to HC-7366 for ...
Posted by Michael Wonder on 23 Oct 2024
FDA approves NGS based companion diagnostic for first targeted therapy for patients with grade 2 IDH mutant glioma
21 October 2024 - Oncomine Dx target test to identify patients eligible for Servier’s Voranigo (vorasidenib) tablet, the only FDA ...
Posted by Michael Wonder on 23 Oct 2024
Health Canada approves first and only oral targeted treatment for brain cancer
22 October 2024 - Pivotal Phase 3 study shows significant improvement in progression-free survival with a favourable safety profile. ...
Posted by Michael Wonder on 23 Oct 2024
Cothera Bioscience announces FDA fast track designation for clinical program PC-002
14 October 2024 - Cothera Bioscience is pleased to announce that the US FDA has granted fast track designation to its ...