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RSS FeedPosted by Michael Wonder on 20 Feb 2018
Acorda announces FDA acceptance of new drug application for Inbrija (levodopa inhalation powder)
20 February 2018 - Acorda Therapeutics today announced that the U.S. FDA has accepted for filing its new drug application for ...
Posted by Michael Wonder on 19 Feb 2018
RMAT vs. breakthrough vs. fast track: companies seek clarity on FDA draft guidance
19 February 2018 - Industry groups BIO, the Alliance for Regenerative Medicine and the International Society for Cellular Therapy, as well ...
Posted by Michael Wonder on 19 Feb 2018
FDA approves Osmotica Pharmaceutical’s once-daily Osmolex ER (amantadine) extended-release tablets for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adults
19 February 2018 - Osmotica Pharmaceutical announced today that the U.S. FDA has approved Osmolex ER, an amantadine extended release tablet, ...
Posted by Michael Wonder on 17 Feb 2018
Allecra Therapeutics announces fast track designation for lead antibiotic in resistant infections
14 February 2018 - Supports Allecra’s lead program in Phase 2 clinical trials to treat serious gram-negative infections. ...
Posted by Michael Wonder on 17 Feb 2018
Apricus Biosciences receives complete response letter from FDA for Vitaros
16 February 2018 - Company evaluating deficiencies and potential path forward. ...
Posted by Michael Wonder on 16 Feb 2018
FDA grants priority review for Genentech’s Rituxan (rituximab) for pemphigus vulgaris
13 February 2018 - The FDA previously granted breakthrough therapy designation and orphan drug designation for Rituxan in pemphigus vulgaris. ...
Posted 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. ...