Blog
RSS FeedPosted by Michael Wonder on 16 Feb 2018
Pfizer receives breakthrough therapy designation from FDA for PF-04965842, an oral JAK1 inhibitor, for the treatment of patients with moderate-to-severe atopic dermatitis
14 February 2018 - Pfizer today announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received breakthrough therapy designation from ...
Posted by Michael Wonder on 16 Feb 2018
Shire announces FDA acceptance of application for Cinryze (C1 esterase inhibitor [human]) for paediatric hereditary angioedema use
15 February 2018 - If approved, Cinryze will be the first and only C1-INH therapy indicated to help prevent HAE attacks ...
Posted by Michael Wonder on 16 Feb 2018
FDA head vows to tackle high drug prices and drug makers ‘gaming the system’
15 February 2018 - FDA Commissioner Scott Gottlieb said he will do everything “within my lane” to combat high drug ...
Posted by Michael Wonder on 16 Feb 2018
FDA opens new path for Alzheimer's treatments
16 February 2018 - Draft guidance comes after Merck failure, years of others. ...
Posted by Michael Wonder on 16 Feb 2018
FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing
16 February 2018 - The U.S. FDA today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell ...
Posted by Michael Wonder on 15 Feb 2018
FDA accepts new drug application and grants priority review for ivosidenib in relapsed or refractory AML with an IDH1 mutation
15 February 2018 - PDUFA date set for 21 August 2018 ...
Posted by Michael Wonder on 15 Feb 2018
Statement from FDA Commissioner on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA’s new drug review programs
15 February 2018 - New medical breakthroughs are altering how diseases are treated in ways that seemed unimaginable just a ...
Posted by Michael Wonder on 15 Feb 2018
AMAG Pharmaceuticals announces FDA approval of Makena (hydroxyprogesterone caproate injection) subcutaneous auto-injector to reduce the risk of preterm birth in certain at-risk women
14 February 2018 - Marks second FDA approval for AMAG this month ...
Posted by Michael Wonder on 14 Feb 2018
The stepped-wedge clinical trial
13 February 2018 - Evaluation by rolling deployment. ...
Posted by Michael Wonder on 14 Feb 2018
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
14 February 2018 - The U.S. FDA today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that ...
Posted by Michael Wonder on 13 Feb 2018
Statement from FDA Commissioner Scott Gottlieb on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
13 February 2018 - Additional resources will help advance initiatives to support novel medical technology and public health priorities such as ...
Posted by Michael Wonder on 13 Feb 2018
Icon Bioscience receives FDA approval for Dexycu, a potentially transformational drug therapy for treating inflammation associated with cataract surgery
12 February 2018 - Icon Bioscience today announced that the United States FDA has approved the company's new drug application for ...
Posted by Michael Wonder on 13 Feb 2018
Sandoz announces US FDA approval and launch of Glatopa 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis
13 February 2018 - Glatopa 40 mg/mL is a fully substitutable, AP-rated generic version of Copaxone (glatiramer acetate injection) 40 mg/mL. ...
Posted by Michael Wonder on 13 Feb 2018
U.S., EU and Japan health authorities accept regulatory submissions for review of Pfizer's third-generation ALK inhibitor lorlatinib
12 February 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 13 Feb 2018
FDA approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to treat the underlying cause of cystic fibrosis in people ages 12 and older with certain mutations in the CFTR gene
12 February 2018 - Symdeko to begin shipping to pharmacies this week. ...