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RSS FeedPosted by Michael Wonder on 28 May 2023
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in patients with tumour cell PD-L1 expression ≥1%
26 May 2023 - Recommendation based on results from the Phase 3 CheckMate-816 trial, in which Opdivo with chemotherapy demonstrated improved ...
Posted by Michael Wonder on 27 May 2023
Iovance Biotherapeutics announces US FDA acceptance of the biologics license application of lifileucel for the treatment of advanced melanoma
26 May 2023 - Priority review granted with PDUFA action date of 25 November 2023. ...
Posted by Michael Wonder on 26 May 2023
Takeda and HUTCHMED announce new drug application for fruquintinib for treatment of previously treated metastatic colorectal cancer granted priority review
25 May 2023 - PDUFA target action date set for 30 November 2023. ...
Posted by Michael Wonder on 26 May 2023
Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...
Posted by Michael Wonder on 25 May 2023
Vanflyta first FLT3 inhibitor approved in Japan for patients with newly diagnosed FLT3-ITD positive AML
25 May 2023 - First FLT3 inhibitor approved in newly diagnosed setting based on QuANTUM-First results demonstrating Vanflyta added to ...
Posted by Michael Wonder on 25 May 2023
Australians battling with prostate cancer to benefit from new PBS listing
25 May 2023 - Australians battling prostate cancer that has spread past the prostate will soon benefit from subsidised medicine ...
Posted by Michael Wonder on 25 May 2023
FORUS Therapeutics and the Pan-Canadian Pharmaceutical Alliance complete negotiations for Xpovio (selinexor)
24 May 2023 - The pCPA agreement will support the public listings and reimbursement of Xpovio. ...
Posted by Michael Wonder on 23 May 2023
Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cancer
22 May 2023 - More than 47,000 new cases of prostate cancer are diagnosed every year in England. ...
Posted by Michael Wonder on 23 May 2023
Lumicell announces FDA acceptance and priority review of new drug application for Lumisight optical imaging agent for breast cancer
22 May 2023 - The system visually highlights cancer that may have otherwise been left behind and is designed to be ...
Posted by Michael Wonder on 22 May 2023
FDA approves Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis
22 May 2023 - Approval based on the positive PIONEER trial, in which once-daily Ayvakit achieved significant improvements in disease symptoms ...
Posted by Michael Wonder on 21 May 2023
Is the quality of evidence in health technology assessment deteriorating over time? A case study on cancer drugs in Australia.
18 May 2023 - This study aimed to assess whether there have been changes in the quality of clinical evidence ...
Posted by Michael Wonder on 19 May 2023
FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
19 May 2023 - Today, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab) for relapsed or refractory diffuse large ...
Posted by Michael Wonder on 18 May 2023
Elevar Therapeutics submits new drug application to FDA for combination of rivoceranib and camrelizumab as first-line treatment option for unresectable hepatocellular carcinoma
17 May 2023 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational ...
Posted by Michael Wonder on 17 May 2023
Drug shortages near an all-time high, leading to rationing
17 May 2023 - A worrisome scarcity of cancer drugs has heightened concerns about the troubled generic drug industry. ...
Posted by Michael Wonder on 17 May 2023
Astellas seeks to expand reimbursement for prostate cancer drug Xtandi
16 May 2023 - Astellas Pharma has set about to rectify the reimbursement track for Xtandi (enzalutamide), its prostate cancer ...