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RSS FeedPosted by Michael Wonder on 18 Dec 2019
PharmaMar has filed new drug application for lurbinectedin with the FDA for the treatment of relapsed small cell lung cancer
17 December 2019 - The application is based on the phase II multicenter basket trial data. ...
Posted by Michael Wonder on 18 Dec 2019
Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma
16 December 2019 - GSK confirms submission of a biologics license application to the US FDA. ...
Posted by Michael Wonder on 17 Dec 2019
Deciphera Pharmaceuticals announces submission of new drug application to U.S. FDA for ripretinib in patients with advanced gastro-intestinal stromal tumours
16 December 2019 - Application is being reviewed under FDA's real-time oncology review pilot program. ...
Posted by Michael Wonder on 17 Dec 2019
Eiger initiates rolling submission of new drug application with FDA for lonafarnib for treatment of progeria and progeroid laminopathies
16 December 2019 - Rolling NDA Submission Planned for Completion in First Quarter 2020. ...
Posted by Michael Wonder on 16 Dec 2019
ITF Pharma announces FDA approval of supplemental new drug application for Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis with a percutaneous endoscopic gastronomy feeding tube
13 December 2019 - Tiglutik is the only formulation of riluzole indicated for both oral and PEG tube administration. ...
Posted by Michael Wonder on 14 Dec 2019
ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir for children living with HIV
13 December 2019 - If approved, this new formulation of DTG will be the first integrase inhibitor available as a dispersible ...
Posted by Michael Wonder on 12 Dec 2019
BioCryst submits new drug application for oral, once daily berotralstat (BCX7353) to prevent HAE attacks
11 December 2019 - BioCryst Pharmaceuticals announced it has submitted a new drug application to the U.S. FDA for approval ...
Posted by Michael Wonder on 12 Dec 2019
Avenue Therapeutics announces submission of new drug application for IV tramadol
11 December 2019 - Avenue Therapeutics today announced that it has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 12 Dec 2019
Kite submits biologics license application to U.S. FDA for Company’s second CAR T cell therapy
11 December 2019 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma if approved. ...
Posted by Michael Wonder on 11 Dec 2019
FDA accepts supplemental biologics license application for Xolair (omalizumab) for the treatment of nasal polyps
10 December 2019 - The submission is based on positive results from the Phase III POLYP 1 and POLYP 2 studies ...
Posted by Michael Wonder on 09 Dec 2019
Sesen Bio initiates rolling submission of BLA for Vicinium to FDA
9 December 2019 - --Sesen Bio today announced that on 6 December 2019, the Company initiated the submission of its biologics ...
Posted by Michael Wonder on 05 Dec 2019
ViiV Healthcare submits new drug application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
5 December 2019 - ViiV Healthcare today completed submission of a new drug application to the US FDA seeking approval of ...
Posted by Michael Wonder on 04 Dec 2019
BridgeBio Pharma’s Origin Biosciences initiates rolling submission of new drug application with the U.S. FDA for BBP-870 for the treatment of MoCD type A
3 December 2019 - BridgeBio Pharma subsidiary Origin Biosciences has initiated a rolling submission of a NDA with the United ...
Posted by Michael Wonder on 04 Dec 2019
Immunomedics resubmits biologics license application to the FDA for sacituzumab govitecan
3 December 2019 - Immunomedics today announced the resubmission of its biologics license application to the U.S. FDA seeking accelerated ...
Posted by Michael Wonder on 03 Dec 2019
Aquestive Therapeutics completes rolling submission of new drug application to U.S. Food and Drug Administration for Libervant (diazepam) buccal film for management of seizure clusters
2 December 2019 - Aquestive Therapeutics today announced the completion, as planned, of the rolling submission of a new drug ...