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RSS FeedPosted by Michael Wonder on 28 Dec 2020
Chi-Med initiates rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
28 December 2020 - Company plans to complete rolling submission in the first half of 2021. ...
Posted by Michael Wonder on 27 Dec 2020
FDA acceptance for the filing of new drug application
23 December 2020 - The Directors are pleased to announce that Polarean has received notification of acceptance of the Company’s NDA ...
Posted by Michael Wonder on 22 Dec 2020
Ocular Therapeutix announces submission to the FDA of a supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular itching associated with allergic conjunctivitis
22 December 2020 - PDUFA target action date anticipated for October 2021. ...
Posted by Michael Wonder on 22 Dec 2020
Jazz Pharmaceuticals announces initiation of biologics license application submission for JZP-458 for the treatment of acute lymphoblastic leukaemia or lymphoblastic lymphoma
21 December 2020 - Application to be reviewed under FDA's Oncology Center of Excellence Real-Time Oncology Review pilot program. ...
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
Oyster Point Pharma submits new drug application to the U.S. FDA for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease
18 December 2020 - The new drug application submission is based on efficacy and safety results from a comprehensive clinical trial ...
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
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
FDA committee to meet again Thursday for Moderna's COVID-19 vaccine
14 December 2020 - A Food and Drug Administration advisory committee will meet for the second time in a week to ...
Posted by Michael Wonder on 15 Dec 2020
U.S. FDA accepts new drug application for review, grants priority review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis
15 December 2020 - If approved, TAK-721 will be the first FDA approved treatment for the chronic inflammatory disease; Takeda plans ...
Posted by Michael Wonder on 10 Dec 2020
Atox Bio announces FDA acceptance to file the NDA for reltecimod to treat suspected organ dysfunction or failure in patients with necrotising soft tissue infection ("flesh eating disease")
10 December 2020 - Atox Bio today announced that the U.S. FDA has accepted to file the new drug application ...
Posted by Michael Wonder on 10 Dec 2020
Pfizer plans to file for full FDA approval of COVID-19 vaccine in April 2021
11 December 2020 - Pfizer said on Thursday it planned to file for full U.S. approval of its experimental coronavirus ...
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 10 Dec 2020
FDA accepts GSK’s filing of Nucala (mepolizumab) for use in chronic rhinosinusitis with nasal polyps
8 December 2020 - If approved, Nucala would be the only treatment approved in the US for use in four eosinophil-driven ...