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RSS FeedPosted by Michael Wonder on 17 Dec 2019
Xtandi (enzalutamide) approved by U.S. FDA for the treatment of metastatic castration-sensitive prostate cancer
16 December 2019 - Xtandi is now FDA approved for the treatment of metastatic castration-sensitive prostate cancer in addition to non-metastatic ...
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 17 Dec 2019
Kura Oncology receives fast track designation for tipifarnib in HRAS mutant HNSCC and provides enrolment guidance for AIM-HN trial
16 December 2019 - Registration-directed AIM-HN trial expected to complete enrolment in first quarter of 2021. ...
Posted by Michael Wonder on 17 Dec 2019
Salarius Pharmaceuticals receives FDA fast track designation for lead drug candidate, seclidemstat, in relapsed or refractory Ewing sarcoma
16 December 2019 - Phase 1/2 clinical study now underway; Salarius targeting key safety and efficacy data milestones in 2020. ...
Posted by Michael Wonder on 16 Dec 2019
Avadel Pharmaceuticals receives U.S. FDA approval for Nouress (AV001), a cysteine hydrochloride injection for treating neonate patients requiring total parental nutrition
16 December 2019 - USPTO issues Orange Book-listed patent for Nouress. ...
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 16 Dec 2019
Senate confirms Stephen Hahn to head FDA
12 December 2019 - The Food and Drug Administration has been without a permanent commissioner since April, when Dr. Scott Gottlieb ...
Posted by Michael Wonder on 14 Dec 2019
FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation
12 December 2019 - The U.S. FDA today granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy ...
Posted by Michael Wonder on 14 Dec 2019
FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups
13 December 2019 - The U.S. FDA today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to ...
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 14 Dec 2019
FDA issues new analysis linking greater generic competition and lower generic drug prices
13 December 2019 - Greater competition among generic drug makers is associated with lower generic drug prices, according to a new ...
Posted by Michael Wonder on 14 Dec 2019
FDA approves Xeljanz XR (tofacitinib) extended-release tablets for the treatment of ulcerative colitis
12 December 2019 - Xeljanz XR provides adult patients living with moderately to severely active UC the first and only once-daily ...
Posted by Michael Wonder on 13 Dec 2019
Sarepta Therapeutics announces FDA approval of Vyondys (golodirsen) injection for the treatment of Duchenne muscular dystrophy in patients amenable to skipping exon 53
12 December 2019 - Vyondys 53 is Sarepta’s second RNA exon-skipping treatment for DMD approved in the U.S. ...
Posted by Michael Wonder on 13 Dec 2019
Y-mAbs’ GD2-GD3 vaccine granted rare paediatric disease designation
12 December 2019 - Y-mAbs Therapeutics today announced that its GD2-GD3 vaccine has been granted a rare paediatric disease designation ...