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RSS FeedPosted 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
Roche receives FDA approval for complementary PD-L1 (SP263) biomarker test in urothelial carcinoma
2 May 2017 - Use of the VENTANA PD-L1 (SP263) assay to determine PD-L1 expression in urothelial carcinoma may help to ...
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
Disclosing the conflicts of interest of US Food and Drug Administration Advisory Committee members
2 May 2017 - The agency excludes many individuals because of conflicts of interest; it may, however, determine that the ...
Posted by Michael Wonder on 02 May 2017
Atlantic Healthcare initiates FDA rolling submission of its new drug application for alicaforsen in the treatment of pouchitis
1 May 2017 - Filing of the nonclinical package marks a key milestone in the process towards obtaining marketing approval ...
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 27 Apr 2017
U.S. top court grapples over making copycat biologics available sooner
26 April 2017 - U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes ...
Posted by Michael Wonder on 27 Apr 2017
FDA approves first treatment for a form of Batten disease
27 April 2017 - The U.S. FDA today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten ...