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RSS FeedPosted by Michael Wonder on 15 Oct 2018
EyePoint Pharmaceuticals receives FDA approval of Yutiq (fluocinolone acetonide 0.18 mg intravitreal implant)
15 October 2018 - The first long-lasting, FDA approved micro-insert for up to three years of continuous control in chronic, non-infectious ...
Posted by Michael Wonder on 15 Oct 2018
Statement by FDA Commissioner on FDA’s new steps to modernise drug development, improve efficiency and promote innovation of targeted therapies
15 October 2018 - The FDA continues to advance new policies, modernise our programs and advance opportunities for developing more targeted ...
Posted by Michael Wonder on 13 Oct 2018
FDA approves Stiolto Respimat supplemental new drug application to add data on COPD exacerbation reduction
11 October 2018 - Stiolto Respimat is the first in its class to have exacerbation data in the product labelling. ...
Posted by Michael Wonder on 12 Oct 2018
U.S. FDA approves Xarelto (rivaroxaban) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease
11 October 2018 - This label expansion adds to six existing Xarelto indications granted since initial launch. ...
Posted by Michael Wonder on 12 Oct 2018
Spero Therapeutics receives QIDP designation from the U.S. FDA for the development of SPR206
11 October 2018 - Spero Therapeutics announced today that SPR206, a product candidate within Spero’s Potentiator Platform, has been granted qualified ...
Posted 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 ...