Blog
RSS FeedPosted by Michael Wonder on 07 May 2017
Post-approval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
3 May 2017 - Between 2005 and 2012 the FDA approved 117 novel drugs for 123 indications on the basis of ...
Posted by Michael Wonder on 06 May 2017
FDA approves drug to treat ALS
5 May 2017 - The U.S. FDA today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred ...
Posted by Michael Wonder on 04 May 2017
Cancer drugs are getting better and dearer
4 May 2017 - AstraZeneca’s Imfinzi costs $180,000 for a year’s treatment. ...
Posted by Michael Wonder on 04 May 2017
The failure of solanezumab — How the FDA saved taxpayers billions
3 May 2017 - The failure of solanezumab offers a window into the U.S. drug regulatory system, particularly in the context ...
Posted by Michael Wonder on 03 May 2017
Pfizer announces U.S. FDA filing acceptance of supplemental new drug application for Xeljanz (tofacitinib citrate) for the treatment of adult patients with active psoriatic arthritis
3 May 2017 - Pfizer announced today that the US FDA has accepted for review the supplemental new drug application for ...
Posted by Michael Wonder on 03 May 2017
BioDelivery Sciences announces the approval of Bunavail for induction of buprenorphine treatment for opioid dependence
2 May 2017 - BioDelivery Sciences announced that the U.S. FDA has approved a supplemental new drug application for Bunavail ...
Posted by Michael Wonder on 03 May 2017
Altor BioScience Corporation announces FDA fast track designation for lead candidate ALT-803 in patients with non-muscle invasive bladder cancer
2 May 2017 - Altor BioScience announced today that it has received fast track designation from the US FDA for its ...
Posted by Michael Wonder on 02 May 2017
Horizon Pharma announces FDA approval to expand the age range for Ravicti (glycerol phenylbutyrate) oral liquid to people with urea cycle disorders two months of age and older
1 May 2017 - Horizon Pharma today announced the U.S. FDA has approved its supplemental new drug application to expand the ...
Posted by Michael Wonder on 02 May 2017
AstraZeneca’s Imfinzi (durvalumab) receives US FDA accelerated approval for previously treated patients with advanced bladder cancer
1 May 2017 - Approval granted regardless of PD-L1 status, based on tumour response rate and duration of response. ...
Posted by Michael Wonder on 01 May 2017
The FDA just approved one of the most expensive drugs in the world
28 April 2017 - Welcome to the latest drug price scandal: a rare disease treatment with a list price of ...
Posted by Michael Wonder on 29 Apr 2017
Accelerating development of scientific evidence for medical products within the existing US regulatory framework
1 May 2017 - Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about ...
Posted by Michael Wonder on 29 Apr 2017
Myriad Genetics and Clovis Oncology sign agreement for use of FDA approved BRACAnalysis CDx test to identify patients with germline BRCA mutations for Rubraca (rucaparib) treatment
27 April 2017 - Myriad Genetics and Clovis Oncology today announced a companion diagnostic collaboration to support a post-marketing regulatory ...
Posted by Michael Wonder on 29 Apr 2017
Takeda announces FDA accelerated approval of Alunbrig (brigatinib)
29 April 2017 - Alunbrig approved for ALK+ metastatic non-small-cell lung cancer patients who have progressed on or are intolerant ...
Posted by Michael Wonder on 29 Apr 2017
FDA approves Radius Health's Tymlos (abaloparatide), a bone building agent for the treatment of postmenopausal women with osteoporosis at high risk for fracture
28 April 2017 - Approval Based on Results at 18 months from the Landmark ACTIVE Trial and the first six months ...
Posted by Michael Wonder on 29 Apr 2017
Novartis receives FDA approval for Rydapt in newly diagnosed FLT3-mutated acute myeloid leukaemia and three types of systemic mastocytosis
28 April 2017 - Rydapt treatment regimen in FLT3-mutated AML demonstrated a significant improvement in overall survival with a 23% ...