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RSS FeedPosted by Michael Wonder on 14 Sep 2020
ESSA Pharma announces fast track designation granted by the FDA to EPI-7386 for the treatment of metastatic castration-resistant prostate cancer
14 September 2020 - ESSA Pharma today announced that the US FDA granted fast track designation to EPI-7386, its oral ...
Posted by Michael Wonder on 11 Sep 2020
Junshi Biosciences receives FDA breakthrough therapy designation for toripalimab for the treatment of nasopharyngeal carcinoma
10 September 2020 - Junshi Biosciences announced today that the US FDA has recently granted breakthrough therapy designation to toripalimab for ...
Posted by Michael Wonder on 10 Sep 2020
Halozyme announces Janssen submission for FDA approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of patients with light chain amyloidosis
10 September 2020 - Follows FDA approval of Darzalex Faspro utilising Enhanze technology in May 2020 for the treatment of patients ...
Posted by Michael Wonder on 05 Sep 2020
Genentech announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion positive non-small cell lung cancer
4 September 2020 - Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. ...
Posted by Michael Wonder on 05 Sep 2020
Kite submits supplemental biologics license application to U.S. FDA for Yescarta in relapsed or refractory indolent non-Hodgkin's lymphomas
4 September 2020 - If approved, Yescarta would be the first CAR T therapy for patients with relapsed or refractory ...
Posted by Michael Wonder on 01 Sep 2020
FDA approves Onureg (azacitidine tablets) for acute myeloid leukaemia
1 September 2020 - Today, the FDA approved azacitidine tablets (Onureg, Celgene) for continued treatment of patients with acute myeloid ...
Posted by Michael Wonder on 01 Sep 2020
Athenex announces FDA acceptance for filing of U.S. NDA for oral paclitaxel and encequidar in metastatic breast cancer with priority review
1 September 2020 - FDA grants priority review and sets PDUFA target action date of 28 February 2021. ...
Posted by Michael Wonder on 31 Aug 2020
VelosBio announces FDA fast track and orphan drug designations for VLS-101 in patients with mantle cell lymphoma
31 August 2020 - VelosBio today announced that the U.S. FDA has granted the company fast track and orphan drug designation ...
Posted by Michael Wonder on 27 Aug 2020
FDA works to evaluate cancer therapies in patients with brain metastases
27 August 2020 - Today, the U.S. FDA issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous ...
Posted by Michael Wonder on 27 Aug 2020
FDA approves Foundation Medicine's FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test with multiple companion diagnostic indications for patients with advanced cancer
26 August 2020 - FDA approval includes companion diagnostic claims for Rubraca (rucaparib), the first PARP inhibitor approved in a prostate ...
Posted by Michael Wonder on 25 Aug 2020
FDA accepts filing of new drug application for tepotinib for the treatment of patients with metastatic NSCLC with METex14 skipping alterations
25 August 2020 - Tepotinib granted priority review and is being evaluated under FDA Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 25 Aug 2020
Turning Point Therapeutics granted fast-track designation for repotrectinib in NTRK positive TKI pre-treated advanced solid tumours
24 August 2020 - Turning Point Therapeutics today announced the FDA granted a third fast-track designation to its lead drug ...
Posted by Michael Wonder on 24 Aug 2020
Exelixis announces submission of supplemental new drug application to U.S. FDA for Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) for advanced renal cell carcinoma
24 August 2020 - Submission based on the phase 3 pivotal CheckMate-9ER trial, which met its primary endpoint of significantly improving ...
Posted by Michael Wonder on 20 Aug 2020
Genmab announces Janssen granted U.S. FDA approval for Darzalex (daratumumab) in combination with carfilzomib and dexamethasone in relapsed or refractory multiple myeloma
20 August 2020 - Approval marks eighth U.S. FDA approval for Darzalex. ...
Posted by Michael Wonder on 20 Aug 2020
Precision BioSciences receives fast track disease designation from U.S. FDA for PBCAR0191 investigational allogeneic CAR T-cell therapy
19 August 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to Precision for PBCAR0191, the ...