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RSS FeedPosted by Michael Wonder on 06 Mar 2021
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 ...
Posted by Michael Wonder on 04 Mar 2021
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 ...
Posted by Michael Wonder on 04 Mar 2021
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. ...
Posted by Michael Wonder on 04 Mar 2021
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 ...
Posted by Michael Wonder on 04 Mar 2021
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 ...
Posted by Michael Wonder on 03 Mar 2021
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 ...
Posted by Michael Wonder on 03 Mar 2021
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 ...
Posted by Michael Wonder on 03 Mar 2021
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 ...
Posted by Michael Wonder on 03 Mar 2021
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. ...
Posted by Michael Wonder on 02 Mar 2021
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 ...
Posted by Michael Wonder on 01 Mar 2021
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 ...
Posted by Michael Wonder on 01 Mar 2021
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 ...
Posted by Michael Wonder on 01 Mar 2021
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 ...
Posted by Michael Wonder on 01 Mar 2021
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 ...
Posted by Michael Wonder on 28 Feb 2021
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 ...