Blog
RSS FeedPosted by Michael Wonder on 15 Dec 2018
FDA approves Nplate (romiplostim) for use in paediatric patients with immune thrombocytopenia
14 December 2018 - Application granted priority review designation. ...
Posted by Michael Wonder on 13 Dec 2018
A method for approximating future entry of generic drugs
13 December 2018 - The paper by Beall and colleagues relates to the development and testing of a method for approximating ...
Posted by Michael Wonder on 13 Dec 2018
Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on efforts to modernise generic drug labels while maintaining the efficiency of generic development
13 December 2018 - Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and ...
Posted by Michael Wonder on 13 Dec 2018
FDA grants fast track designation to the baricitinib development program for the treatment of systemic lupus erythematosus
13 December 2018 - Eli Lilly and Incyte announced today that the U.S. FDA has granted fast track designation to ...
Posted by Michael Wonder on 13 Dec 2018
Authorized generic for Evzio (naloxone hydrochloride injection) to be available at a reduced list price of $178
12 December 2018 - Product will be available in 2019. ...
Posted by Michael Wonder on 12 Dec 2018
Mallinckrodt's SpecGx receives FDA complete response letter for abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride)
12 December 2018 - SpecGx announced today that it has received a complete response letter from the U.S. FDA related ...
Posted by Michael Wonder on 12 Dec 2018
FDA takes aim at pharma’s biosimilar-delaying tactics
12 December 2018 - Ever-rising cost of insulins also to be targeted. ...
Posted by Michael Wonder on 12 Dec 2018
Metastasis-free survival in prostate cancer: faster drug approvals, better drugs?
12 December 2018 - On 13 February 2018, the US FDA granted marketing authorisation to apalutamide for treatment of non-metastatic castration-resistant ...
Posted by Michael Wonder on 12 Dec 2018
Bayesian hierarchical models
11 December 2018 - Treatment effects will differ from one study to another evaluating similar therapies, both because of random variation ...
Posted by Michael Wonder on 12 Dec 2018
Mayne Pharma receives FDA approval of Tolsura (SUBA-itraconazole capsules) for the treatment of certain fungal infections
11 December 2018 - Mayne Pharma is pleased to announce that the US FDA has approved the new drug application ...
Posted by Michael Wonder on 11 Dec 2018
Non-cystic fibrosis bronchiectasis FDA grants “fast-track” and “QIPD” to Zambon for colistimethate sodium powder for nebuliser solution delivered by the I-neb AAD system
11 December 2018 - Non–cystic fibrosis bronchiectasis is a, chronic, progressive and irreversible disease, prevalent in Europe and the US. ...
Posted by Michael Wonder on 11 Dec 2018
The drug industry is headed back to Congress to make its case. Will Democrats keep the door open?
10 December 2018 - With annual revenues of roughly $450 million and an army of some 160 lobbyists, PhRMA has ...
Posted by Michael Wonder on 11 Dec 2018
Intra-Cellular Therapies announces FDA acceptance of new drug application for lumateperone for the treatment of schizophrenia
11 December 2018 - Intra-Cellular Therapies today announced that the U.S. FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 11 Dec 2018
Statement from FDA Commissioner on new actions advancing the agency’s biosimilars policy framework
11 December 2018 - Our public health obligations touch on many aspects of how medical products are developed and used ...
Posted by Michael Wonder on 10 Dec 2018
Stealth BioTherapeutics granted fast track designation for elamipretide for the treatment of dry age-related macular degeneration with geographic atrophy
10 December 2018 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead investigational ...