On June 24, 2022, the US Food and Drug Administration issued a draft guidance document on the Considerations for Rescinding Breakthrough Therapy Designation. The guidance explains how.
28.07.2022 - Relief Therapeutics Holding SA / Key word(s): Regulatory Admission Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Review of NDA Resubmission for ACER-001 for Treatment of UCDs 28-Jul-2022 / 07:00 CET/CEST Release of an ad . Seite 1
Relief Therapeutics Holding SA / Key word(s): Regulatory Admission Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Review of NDA Resubmission for ACER-001 for Treatment of UCDs
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17.06.2022 - -Yselty (linzagolix) is the first and only approved GnRH antagonist to provide flexible dosing options with and without hormonal add-back therapy- -Theramex to commercialize Yselty; ObsEva to receive royalties on commercial sales, as well as . Seite 1