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RSS FeedPosted by Michael Wonder on 13 Jun 2018
FDA grants rare paediatric disease designation to A4250; Albireo eligible to apply for priority review voucher
12 June 2018 - Albireo Pharma a clinical-stage orphan paediatric liver disease company developing novel bile acid modulators, today announced the ...
Posted by Michael Wonder on 13 Jun 2018
Nordic Nanovector announces Betalutin has been granted fast track designation in the US for follicular lymphoma
12 June 2018 - Nordic Nanovector announces that the US FDA has granted fast track designation to Betalutin (177Lu-lilotomab satetraxetan) ...
Posted by Michael Wonder on 13 Jun 2018
RegenxBio receives FDA fast track designation for RGX-111 gene therapy for the treatment of mucopolysaccharidosis type I
12 June 2018 - Phase I clinical trial expected to enroll children and adults with MPS I. ...
Posted by Michael Wonder on 13 Jun 2018
FDA approves Merck’s Keytruda (pembrolizumab) for previously treated patients with recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS greater than or equal to 1)
12 June 2018 - Keytruda now first anti-PD-1 therapy approved for patients with advanced cervical cancer and disease progression on or ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
12 June 2018 - The increase in serious antimicrobial drug resistant infections is a critical public health concern and a ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new efforts to advance medical product communications to support drug competition and value-based health care
12 June 2018 - We’re living in a time of unparalleled scientific advancement. Innovative medical treatments continue to be developed ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
12 June 2018 - Over the past decade, advances in our understanding of the basic biology of serious and life-threatening ...
Posted by Michael Wonder on 12 Jun 2018
FDA approves addition of positive overall survival data from Phase 3 ASPIRE trial to Kyprolis (carfilzomib) label
11 June 2018 - Kyprolis, lenalidomide and dexamethasone extended median overall survival in relapsed or refractory multiple myeloma patients to 48 ...
Posted by Michael Wonder on 09 Jun 2018
Clinical trial design and dissemination: comprehensive analysis of clinicaltrials.gov and PubMed data since 2005
6 June 2018 - Well conducted clinical trials are widely regarded as the best source of evidence on the efficacy and ...
Posted by Michael Wonder on 09 Jun 2018
Easier drug approval isn’t cutting drug prices
8 June 2018 - Dr. Scott Gottlieb, the commissioner of the FDA, recently vowed to bring “new science” to market ...
Posted by Michael Wonder on 09 Jun 2018
AbbVie announces U.S. FDA approval of Venclexta (venetoclax tablets) in combination with rituximab as a fixed duration treatment for chronic lymphocytic leukaemia or small lymphocytic lymphoma patients who have received one prior therapy
8 June 2018 - Patients receiving Venclexta plus rituximab achieved a high overall response rate of 92%. ...
Posted by Michael Wonder on 07 Jun 2018
FDA approves Genentech’s Rituxan (rituximab) for pemphigus vulgaris
7 June 2018 - Rituxan is now FDA-approved to treat four auto-immune diseases. ...
Posted by Michael Wonder on 07 Jun 2018
U.S. FDA and EMA accept regulatory submissions for review of tazaloparib for metastatic breast cancer patients with an inherited BRCA mutation
7 June 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 07 Jun 2018
The ‘right to try’ law says yes, the drug company says no
6 June 2018 - Vibhav Rangarajan and Sonal Patel, doctors in Chicago, learned in April that their 2-year-old daughter, Radha, has ...
Posted by Michael Wonder on 07 Jun 2018
Intra-Cellular Therapies initiates rolling submission of new drug application for lumateperone for treatment of schizophrenia
6 June 2018 - Intra-Cellular Therapies today announced the initiation of a rolling submission of its new drug application with the ...