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RSS FeedPosted by Michael Wonder on 07 Apr 2019
Abeona Therapeutics receives FDA fast track designation for ABO-101 for treatment of Sanfilippo syndrome type B
4 April 2019 - Ongoing Phase 1/2 study of ABO-101 enrolling eligible patients with MPS IIIB. ...
Posted by Michael Wonder on 04 Apr 2019
The importance of predefined rules and pre-specified statistical analyses: do not abandon significance
4 April 2019 - For decades, statisticians and clinicians have debated the meaning of statistical and clinical significance. ...
Posted by Michael Wonder on 04 Apr 2019
FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development
4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...
Posted by Michael Wonder on 04 Apr 2019
Daiichi Sankyo provides update on ongoing FDA review for quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
4 April 2019 - Daiichi Sankyo today announced that the U.S. FDA has extended the review period for the new ...
Posted by Michael Wonder on 04 Apr 2019
FDA expands approved use of metastatic breast cancer treatment to include male patients
4 April 2019 - The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination ...
Posted by Michael Wonder on 04 Apr 2019
Ondine Biomedical receives fast track designation from the U.S. FDA for nasal photodisinfection system
3 April 2019 - Ondine Biomedical today announced that the U.S. FDA has granted fast track designation to its fixed-dose combination ...
Posted by Michael Wonder on 04 Apr 2019
Immunocore’s lead asset tebentafusp gains fast track designation for metastatic uveal melanoma
3 April 2019 - Immunocore today announces that the U.S. FDA has granted fast track designation for its development program, ...
Posted by Michael Wonder on 04 Apr 2019
FDA approves the reintroduction of Zelnorm (tegaserod) for irritable bowel syndrome with constipation in women under 65
1 April 2019 - In clinical trials, patients taking Zelnorm saw improvement in some of the most bothersome IBS-C symptoms, including ...
Posted by Michael Wonder on 04 Apr 2019
Ocular Therapeutix announces notification of FDA acceptance of supplemental new drug submission for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular inflammation following ophthalmic surgery
2 April 2019 - PDUFA target action date set for 10 November 2019 ...
Posted by Michael Wonder on 03 Apr 2019
Overprescribed: high cost isn’t America’s only drug problem
2 April 2019 - The pharmaceutical industry has followed a brilliant two-pronged strategy to maximize its profits: raise prices and ...
Posted by Michael Wonder on 03 Apr 2019
Gottlieb signs off with flair – and pledge of further drug price commentary
3 April 2019 - Highlights issues of insulin prices and competition. ...
Posted by Michael Wonder on 03 Apr 2019
FDA approves Asceniv, a novel intravenous immune globulin
1 April 2019 - Approved for use in the treatment of primary humoral immunodeficiency disease in adults and adolescents (12 to ...
Posted by Michael Wonder on 03 Apr 2019
Evoke Pharma receives complete response letter and recommendations to address deficiencies from FDA for Gimoti NDA
2 April 2019 - Evoke Pharma today announced that it has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 03 Apr 2019
Sandoz resubmits biosimilar pegfilgrastim application to US FDA
2 April 2019 - Sandoz pursues US approval for biosimilar pegfilgrastim, a long-acting version of supportive oncology medicine filgrastim. ...
Posted by Michael Wonder on 02 Apr 2019
Statement from FDA Commissioner on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access
2 April 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes. ...