Blog
RSS FeedPosted by Michael Wonder on 28 Nov 2019
Hikma completes its FDA response for generic Advair
27 November 2019 - Hikma Pharmaceuticals today announces that it has submitted to the US FDA its response to deficiencies in ...
Posted by Michael Wonder on 28 Nov 2019
Incyte announces acceptance and priority review of NDA for pemigatinib as a treatment for patients with cholangiocarcinoma
27 November 2019 - Incyte today announced that the U.S. FDA has accepted for Priority Review its new drug application for ...
Posted by Michael Wonder on 27 Nov 2019
Evofem Biosciences resubmits new drug application to U.S. FDA for Amphora for the prevention of pregnancy
26 November 2019 - FDA decision anticipated within six months. ...
Posted by Michael Wonder on 27 Nov 2019
Our drug policy often prioritises eliminating rare disease. One researcher asks: Is that the right goal?
26 November 2019 - Dr. Peter Bach wants to turn the entire philosophical underpinnings of America’s health care system upside ...
Posted by Michael Wonder on 27 Nov 2019
Revance submits biologics license application to the FDA for DAXI to treat glabellar (frown) lines
25 November 2019 - Revance Therapeutics today announced the Company has submitted a biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 26 Nov 2019
Teva, drug makers in talks with U.S. to end generics probes
26 November 2019 - Deferred prosecution agreements among resolutions discussed. ...
Posted by Michael Wonder on 26 Nov 2019
Phathom Pharmaceuticals provides corporate update
25 November 2019 - Received qualified infection disease pathogen designation from the U.S. FDA for vonoprazan in combination with both amoxicillin ...
Posted by Michael Wonder on 25 Nov 2019
FDA approves voxelotor for sickle cell disease
25 November 2019 - The Food and Drug Administration has granted accelerated approval to voxelotor (Oxbryta, Global Blood Therapeutics) for ...
Posted by Michael Wonder on 25 Nov 2019
FDA accepts Intercept’s new drug application for OCA for the treatment of liver fibrosis due to NASH and grants priority review
25 November 2019 - NDA supported by positive interim analysis results from the Phase 3 REGENERATE study demonstrating OCA’s improvement of ...
Posted by Michael Wonder on 25 Nov 2019
Zogenix announces FDA acceptance for filing of new drug application and priority review for Fintelpa for the treatment of Dravet syndrome
25 November 2019 - NDA supported by data from two pivotal Phase 3 trials in Dravet syndrome, both of which met ...
Posted by Michael Wonder on 25 Nov 2019
Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
25 November 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes. ...
Posted by Michael Wonder on 25 Nov 2019
FDA grants priority review to Roche’s risdiplam for spinal muscular atrophy
25 November 2019 - Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people ...
Posted by Michael Wonder on 25 Nov 2019
FDA approves Aquestive's ALS treatment
22 November 2019 - The U.S. Food and Drug Administration on Friday approved Aquestive Therapeutics’ treatment for neurological disorder amyotrophic ...
Posted by Michael Wonder on 24 Nov 2019
Lifecycle regulation of artificial intelligence and machine learning–based software devices in medicine
22 November 2019 - Artificial intelligence and machine learning (AI/ML) based technologies aim to improve patient care by uncovering new ...
Posted by Michael Wonder on 24 Nov 2019
Sunovion resubmits new drug application for apomorphine sublingual film
22 November 2019 - Sunovion Pharmaceuticals today announced the resubmission of the new drug application to the U.S. FDA for ...