Brief: Obseva Announces U.S. FDA Acceptance Of New Drug Application For Linzagolix
22/11/2021 06:23
Nov 22 (Reuters) - Obseva Sa OBSN.S :
* OBSEVA ANNOUNCES U.S. FDA ACCEPTANCE OF NEW DRUG
APPLICATION FOR
LINZAGOLIX
* FDA SET A TARGET ACTION DATE OF SEPTEMBER 13, 2022 FOR
THIS NDA
UNDER PRESCRIPTION DRUG USER FEE ACT (PDUFA)
* LINZAGOLIX MARKETING AUTHORIZATION APPLICATION WAS
VALIDATED BY
EMA FOR HUMAN USE (CHMP) EXPECTED IN Q4 2021
Source text for Eikon: ID:nGNX7rm3bM
Further company coverage: OBSN.S
((Reuters.Briefs@thomsonreuters.com;))
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