Adamis provides update on Zimhi

9 June 2021 - FDA deems new drug application for Zimhi complete and establishes a target action date of 12 November ...

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Incyte announces U.S. FDA has extended the sNDA review period for ruxolitinib (Jakafi) in chronic graft versus host disease

8 June 2021 - Incyte today announced that the U.S. FDA has extended the review period for the supplemental new drug ...

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Verrica Pharmaceuticals announces extension of FDA review period of its NDA for VP-102 for the treatment of molluscum contagiosum

28 May 2021 - Prescription Drug User Fee Act goal date extended by three months to 23 September 2021. ...

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Omeros announces extension of FDA review period for narsoplimab in HSCT-TMA

20 May 2021 - PDUFA date is 17 October 2021. ...

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Adamis Pharmaceuticals provides an update on Zimhi

12 April 2021 - Adamis Pharmaceuticals today provided an update on the status of the company’s new drug application relating ...

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Provention Bio provides regulatory update on biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals

8 April 2021 - Provention Bio today announced that the company received a notification on 2 April 2021 from the U.S. ...

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Pfizer announces extension of review of new drug application of abrocitinib for the treatment of moderate to severe atopic dermatitis

7 April 2021 - Pfizer today announced that the U.S. FDA has extended the priority review period for the new ...

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Lilly and Incyte communicate review extension of supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis

6 April 2021 - Eli Lilly and Incyte announced today that the U.S. FDA has extended the review period for ...

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AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of moderate to severe atopic dermatitis

2 April 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...

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Too fast or too slow: is the FDA moving at the right speed?

19 March 2021 - Regardless of President Joe Biden’s choice for the next commissioner of the FDA, the Senate Health, Education, ...

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AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of adults with active psoriatic arthritis

17 March 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...

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Confirmation of Technigas US FDA timetable

12 March 2021 - Cyclopharm has provided an update of the US FDA’s timetable in respect of approval of the Company’s ...

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Pandemic forces FDA to sharply curtail drug company inspections

9 March 2021 - The steep decline in oversight has stalled a number of new drug applications.  ...

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Drug industry pushes FDA to solve growing inspection backlog

2 March 2021 - Inspections are a vital tool to ensure the safety of new drugs as well as medicines already ...

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Three steps can help companies speed FDA approval of new drugs

24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and ...

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