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RSS FeedPosted by Michael Wonder on 11 Oct 2018
FDA approves new DNA-based test to determine blood compatibility
11 October 2018 - Test is first approved to report genotypes as final results. ...
Posted by Michael Wonder on 11 Oct 2018
FDA again approves record-breaking number of generic drugs
11 October 2018 - The FDA approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ...
Posted by Michael Wonder on 10 Oct 2018
Cure for cancer would become more likely if FDA streamlined the drug approval process
10 October 2018 - The Biden Cancer Initiative recently hosted a meeting in Washington, D.C., pursuant to former vice president ...
Posted by Michael Wonder on 10 Oct 2018
Questions about funding and purpose loom over a foundation Congress created to help the FDA
9 October 2018 - A little-known nonprofit established by Congress over 10 years ago to help the FDA work with ...
Posted by Michael Wonder on 09 Oct 2018
Recro Pharma announces PDUFA date for IV meloxicam
8 October 2018 - PDUFA Date Set for 24 March 2019. ...
Posted by Michael Wonder on 09 Oct 2018
Statement from FDA Commissioner on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
9 October 2018 - As part of the U.S. FDA’s efforts to promote drug competition and patient access, we’ve advanced ...
Posted by Michael Wonder on 08 Oct 2018
Bausch Health's Bryhali (halobetasol propionate) 0.01% lotion receives tentative FDA approval for plaque psoriasis in adults
8 October 2018 - Company plans to launch Bryhali lotion in November 2018 upon final FDA approval. ...
Posted by Michael Wonder on 08 Oct 2018
Acacia Pharma provides update on FDA regulatory review of Barhemsys
8 October 2018 - FDA issued a complete response letter to Acacia Pharma on Friday 5 October. ...
Posted by Michael Wonder on 08 Oct 2018
FDA allows marketing of first self-fitting hearing aid controlled by the user
5 October 2018 - The U.S. FDA today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify ...
Posted by Michael Wonder on 08 Oct 2018
Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients
8 October 2018 - If approved, siponimod (BAF312) would be the first oral disease-modifying therapy with the potential to delay progression ...
Posted by Michael Wonder on 08 Oct 2018
Valneva announces FDA approval of accelerated Ixiario vaccination schedule
5 October 2018 - Valneva announced today that the U.S. FDA has approved an alternate Ixiaro immunisation schedule of two doses ...
Posted by Michael Wonder on 08 Oct 2018
Akcea announces its access and distribution strategy for Tegsedi (inotersen)
5 October 2018 - Express Scripts’ Accredo selected as specialty pharmacy for its expertise in providing timely access and support services ...
Posted by Michael Wonder on 06 Oct 2018
U.S. FDA accepts Karyopharm’s new drug application for selinexor and grants priority review
5 October 2018 - Application seeks accelerated approval for selinexor as a treatment for patients with penta-refractory multiple myeloma. ...
Posted by Michael Wonder on 06 Oct 2018
FDA approves Revcovi, a new enzyme replacement therapy developed by Leadiant Biosciences, for the treatment of ADA-SCID in paediatric and adult patients
5 October 2018 - Leadiant Biosciences today announced that the FDA has granted approval to Revcovi (elapegademase-lvlr) injection in the ...
Posted by Michael Wonder on 05 Oct 2018
Evaluating progression-free survival as a surrogate outcome for health-related quality of life in oncology
1 October 2018 - Progression-free survival has become a commonly used outcome to assess the efficacy of new cancer drugs. However, ...