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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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.  ...

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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 ...

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