U.S. FDA approves Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

5 March 2021 - Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third ...

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Blueprint Medicines announces EMA validation of type II variation marketing authorisation application for Ayvakyt (avapritinib) for the treatment of advanced systemic mastocytosis

3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...

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Junshi Biosciences and Coherus BioSciences announce initiation of rolling submission of BLA for toripalimab to the U.S. FDA for the treatment of nasopharyngeal carcinoma

3 March 2021 - BLA submitted with FDA’s breakthrough therapy designation. ...

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U.S. FDA expands approval of Pfizer's Lorbrena as first-line treatment for ALK positive metastatic lung cancer

3 March 2021 - Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or ...

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NICE rejects rare blood cancer treatment Poteligeo in final appraisal

4 March 2021 - The UK’s NICE has not recommended Kyowa Kirin’s Poteligeo for the treatment of adults living with ...

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On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery

3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...

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Oblato announces fast track designation of OKN-007 for diffuse intrinsic pontine glioma from the FDA

3 March 2021 - Oblato announces that the FDA granted fast track designation of OKN-007, the proprietary drug for diffuse intrinsic ...

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Cancer patient told palliative care only option after being rejected PHARMAC funding

2 March 2021 - The drug-buying agency was placed under an independent review today after the Prime Minister said she ...

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Health Canada approves Brukinsa (zanubrutinib) for the treatment of Waldenström’s macroglobulinaemia

2 March 2021 - Approval is based on the Phase 3 ASPEN trial of Brukinsa compared to ibrutinib. ...

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Merck provides update on Keytruda (pembrolizumab) indication in metastatic small cell lung cancer in the US

1 March 2021 - Merck today announced the company is voluntarily withdrawing the U.S. indication for Keytruda (pembrolizumab) for the treatment ...

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Agios submits supplemental new drug application to FDA for Tibsovo (ivosidenib) for patients with previously treated IDH1 mutant cholangiocarcinoma

1 March 2021 - Agios Pharmaceuticals today announced that it has submitted a Supplemental new drug application to the U.S. FDA ...

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Athenex receives FDA complete response letter for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer

1 March 2021 - Athenex today announced that the U.S. FDA has issued a complete response letter for the company’s ...

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FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma

26 February 2021 - Today the FDA granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone ...

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Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for retifanlimab as a treatment for patients with squamous cell anal carcinoma

26 February 2021 - Incyte today announced the validation of the Company’s marketing authorisation application for retifanlimab, an intravenous PD-1 ...

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GSK receives CHMP positive opinion recommending approval of dostarlimab for women with recurrent or advanced endometrial cancer

26 February 2021 - GlaxoSmithKline today announced the CHMP of the EMA has adopted a positive opinion recommending dostarlimab, an anti-programmed ...

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