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Camurus announces PDUFA date for Brixadi for the treatment of opioid use disorder in the US firstwordpharma
June 28, 2021
Camurus announced today that the NDA by Camurus' US licensee Braeburn for Brixadi™ (buprenorphine) extended-release weekly and monthly injection for subcutaneous use for moderate to severe opioid use disorder was accepted for review by the FDA.
Provention Bio Announces Teplizumab BLA for Delay or Prevention of Clinical T1D americanpharmaceuticalreview
January 11, 2021
Provention Bio announced the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA).
Xeris Pharmaceuticals Receives Notification of PDUFA Date Extension for Gvoke drugs
June 14, 2019
Xeris Pharmaceuticals Receives Notification of PDUFA Date Extension for Gvoke.
Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia pharmafocusasia
March 12, 2019
Eisai Co., Ltd. and Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P. (President and CEO: Craig Landau, MD), today announced that the U.S. Food and Drug Administration (FDA) has accepted f
FDA recalls inspectors as shutdown drags on; Gottlieb calls PDUFA most 'vulnerable' fiercepharma
January 17, 2019
The FDA is recalling some furloughed employees to restart inspections despite a government shutdown. (FDA)
FDA Approves Removal of "Not for Home Use" Label Restriction for Pliaglis americanpharmaceuticalreview
December 19, 2018
Crescita Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) for.....
Teva Confirms September PDUFA Date for Fremanezumab drugs
June 12, 2018
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today confirmed that the U.S. Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for fremanezumab
An Overview of the User Fee Systems concerning the U.S. Pharmaceutical Product Review en-cphi.cn
November 06, 2017
The U.S. government promulgated the FDA Reauthorization Act of 2017 (FDARA) in August 2017.Let's learn about those user fee systems one by one.