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RSS FeedPosted by Michael Wonder on 21 Dec 2020
The FDA grants IO Biotech breakthrough therapy designation for IO102 and IO103 in combination with anti-PD-1 in unresectable/metastatic melanoma
15 December 2020 - IO Biotech today announced that the U.S. FDA has granted breakthrough therapy designation for a combination ...
Posted by Michael Wonder on 21 Dec 2020
Janssen initiates rolling submission of a biologics license application to U.S. FDA for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the ...
Posted by Michael Wonder on 21 Dec 2020
Sesen Bio submits completed biologics license application to the FDA for Vicineum and has requested priority review
21 December 2020 - BLA supported by strong Phase 3 VISTA trial data and positive analytical comparability data. ...
Posted by Michael Wonder on 21 Dec 2020
U.S. FDA approves supplemental new drug application for Takeda’s Iclusig (ponatinib) for adult patients with resistant or intolerant chronic phase CML
19 December 2020 - Approval based on data from the Phase 2 OPTIC trial, which evaluated response-based Iclusig dosing regimens in ...
Posted by Michael Wonder on 19 Dec 2020
Karyopharm announces FDA approval of Xpovio (selinexor) as a treatment for patients with multiple myeloma after at least one prior therapy
18 December 2020 - Oral Xpovio now available as a treatment option for patients with multiple myeloma as early as first ...
Posted by Michael Wonder on 18 Dec 2020
FDA approves first adjuvant therapy for most common type of lung cancer
18 December 2020 - Today, the U.S. FDA approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell ...
Posted by Michael Wonder on 18 Dec 2020
FDA approves first oral hormone therapy for treating advanced prostate cancer
18 December 2020 - Today, the U.S. FDA approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. ...
Posted by Michael Wonder on 18 Dec 2020
Blueprint Medicines submits supplemental new drug application to FDA for Ayvakit (avapritinib) for the treatment of advanced systemic mastocytosis
17 December 2020 - Blueprint Medicines today announced the submission of a supplemental new drug application to the U.S. Food FDA ...
Posted by Michael Wonder on 17 Dec 2020
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic oesophageal and gastro-esophageal junction cancer
17 December 2020 - Application based on overall survival and progression-free survival data comparing Keytruda plus chemotherapy to chemotherapy alone from ...
Posted by Michael Wonder on 17 Dec 2020
MacroGenics announces FDA approval of Margenza for patients with pretreated metastatic HER2 positive breast cancer
16 December 2020 - Product launch anticipated in March of 2021. ...
Posted by Michael Wonder on 17 Dec 2020
Amgen submits sotorasib new drug application to U.S. FDA for advanced or metastatic non-small cell lung cancer with KRAS G12C mutation
16 December 2020 - FDA granted breakthrough therapy designation for Sotorasib. ...
Posted by Michael Wonder on 15 Dec 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of acute myeloid leukaemia
15 December 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 14 Dec 2020
Avelas receives FDA breakthrough therapy designation for pegloprastide (AVB-620) for use during breast cancer surgery
14 December 2020 - Avelas Biosciences today announced that the company has received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 10 Dec 2020
Lantheus Holdings announces acceptance and priority review of new drug application for PyLTM (18F DCFPyL), a PSMA targeted prostate cancer PET imaging agent
9 December 2020 - PDUFA action date of 28 May 2021 assigned by U.S. FDA. ...
Posted by Michael Wonder on 09 Dec 2020
Amgen's sotorasib granted breakthrough therapy designation for advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation
8 December 2020 - Sotorasib also accepted into FDA's Real-Time Oncology Review pilot program. ...