Page 2 - Regulatory Sciences News Today

CAMBRIDGE, Mass., Jan. 05, 2023Inc. (Nasdaq: BIIB) announced that Priya Singhal, M.D., M.P.H., currently Head of Global Safety and Regulatory Sciences and Interim Head of Research & Development (R&D),

06.12.2022 - Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major ... Seite 1

The EMA has accepted the marketing authorisation application for tofersen, which could be the first treatment for a rare genetic cause of ALS.

SOD1-ALS is a rare, genetic form of ALS,1 comprising approximately 2% of people with ALS2If approved, tofersen would be the first treatment to target a genetic cause of ALS CAMBRIDGE, Mass., Dec. ... | December 5, 2022

WESTON (dpa-AFX) - Biogen Inc. (BIIB) announced Monday that the European Medicines Agency or EMA has accepted the Marketing Authorization Application or MAA for review of tofersen to treat rare

BioPharma

The Food and Drug Administration (FDA) has extended the review periods for 2 investigational products: sparsentan and tofersen.

The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is April 25, 2023 CAMBRIDGE, Mass., Oct. 17, 2022Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration

British American Tobacco Plc released Thursday the preliminary results of its latest research study, this time evaluating its oral nicotine product Velo of R.J. Reynolds Tobacco Co.

TCELS, in collaboration with the Asia-Pacific Life Sciences cluster, is organising the Bio Asia Pacific 2022 event, linking researchers and investors in support of medical-health research at the industrial level, as well as improving the quality of life and driving the economy forward.