FDA Accepts Novan’s NDA for Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum with a PDUFA Goal Date of January 5, 2024
07 mars 2023 08h00 HE
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Novan, Inc.
– FDA completes filing review of application with no filing issues identified – – New Chemical Entity (“NCE”) has potential to be the first FDA-approved prescription product for molluscum in the...
Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum
06 janv. 2023 08h00 HE
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Novan, Inc.
– Potential FDA approval anticipated in first quarter 2024, assuming the filing is accepted by the FDA and under standard review timelines – – Molluscum contagiosum is a viral skin infection that...
Novan to Present Berdazimer Gel, 10.3% (SB206) Clinical Data at Annual Meeting of the Society for Investigative Dermatology
19 mai 2022 09h05 HE
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Novan, Inc.
– Based on clinical data from previously completed B-SIMPLE4 pivotal Phase 3 clinical study, berdazimer gel, 10.3% (SB206) can shorten the duration of molluscum infection and increase the chance of...
Novan Reports Full Year 2021 Financial Results and Provides Corporate Update
22 févr. 2022 07h00 HE
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Novan, Inc.
– First New Drug Application (NDA) submission targeted in Q4 2022 for lead program SB206 (berdazimer gel 10.3%) for molluscum contagiosum – – Ongoing advancement of priority development pipeline...
Novan to Report Full Year 2021 Financial Results on February 22, 2022
15 févr. 2022 09h00 HE
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Novan, Inc.
DURHAM, N.C., Feb. 15, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that it will report its full year 2021 financial results on Tuesday, February...
Novan Provides Corporate Update and Reports Third Quarter 2021 Financial Results
10 nov. 2021 05h55 HE
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Novan, Inc.
– Company executing on plans for three potential New Drug Application (NDA) filings in three years with the first submission targeted in Q3 2022 for lead program SB206 in molluscum contagiosum – –...
Novan to Report Third Quarter 2021 Financial Results on November 10, 2021
03 nov. 2021 09h00 HE
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Novan, Inc.
DURHAM, N.C., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that it will report its third quarter 2021 financial results on Wednesday,...
Novan Appoints Brian M. Johnson as Chief Commercial Officer and Receives Conditional FDA Acceptance of Proposed Brand Name KINSOLUS™ for SB206 in Molluscum Contagiosum
02 nov. 2021 08h30 HE
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Novan, Inc.
– Mr. Johnson brings broad commercial expertise with over 30 years of leadership spanning dermatology marketing, sales, sales management, digital marketing and managed care –– Company received...
Novan Reports Safety Data from B-SIMPLE4 Pivotal Phase 3 Study of SB206
23 sept. 2021 08h00 HE
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Novan, Inc.
– SB206 demonstrates continued favorable safety profile consistent with previous studies and meets Company’s expectations – – Pre-NDA meeting with the FDA, as well as conduct of customary stability...
Novan Engages Syneos Health as Commercial Solutions Provider for SB206
08 sept. 2021 09h00 HE
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Novan, Inc.
– Company targeting New Drug Application (NDA) for SB206 in Q3 2022, following recent clinically and statistically significant topline efficacy results from a pivotal Phase 3 B-SIMPLE4 trial in...