Saturday, September 19, 2020 12:19:26 PM
About Orphan Drug Designation
Under the Orphan Drug Act (ODA), the FDA may grant orphan drug designation to drugs intended to treat rare diseases or conditions that affect fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active moiety to treat a particular disease with FDA orphan drug designation is entitled to various incentives of the ODA, including tax credits for qualified clinical testing, waiver of new drug application (NDA) / biologics license application (BLA) user fees, and eligibility for a seven-year exclusive marketing period for that drug and use upon marketing approval.
Recent ZYNE News
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/09/2024 12:22:51 AM
- Form 15-12G - Securities registration termination [Section 12(g)] • Edgar (US Regulatory) • 10/19/2023 08:48:36 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 10/12/2023 04:15:05 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/11/2023 02:17:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/11/2023 02:12:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/11/2023 02:05:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/11/2023 02:02:08 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 10/11/2023 01:27:41 PM
- Form S-8 POS - Securities to be offered to employees in employee benefit plans, post-effective amendments • Edgar (US Regulatory) • 10/11/2023 01:27:00 PM
- Form SC 14D9/A - Solicitation, recommendation statements: [Amend] • Edgar (US Regulatory) • 10/11/2023 12:56:22 PM
- Form SC TO-T/A - Tender offer statement by Third Party: [Amend] • Edgar (US Regulatory) • 10/11/2023 12:31:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/11/2023 12:17:36 PM
- HARMONY BIOSCIENCES COMPLETES ACQUISITION OF ZYNERBA PHARMACEUTICALS AND EXPANDS PIPELINE • PR Newswire (US) • 10/11/2023 12:00:00 PM
- Form SC 14D9/A - Solicitation, recommendation statements: [Amend] • Edgar (US Regulatory) • 10/04/2023 09:29:21 PM
- Important Information for Zynerba Pharmaceuticals Stockholders to Tender Shares for the Harmony Transaction: Process and Instructions • GlobeNewswire Inc. • 10/04/2023 08:05:00 PM
- Zynerba Pharmaceuticals Stockholders Reminded to Tender Shares Before 5:00 PM New York City Time, on Tuesday October 10, 2023 • GlobeNewswire Inc. • 09/29/2023 01:00:00 PM
FEATURED Cannabix Technologies Launches New Compact Breath Logix Workplace Series and Prepares for Delivery to South Africa • May 7, 2024 8:51 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM