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Skyclarys Approved for Friedreich Ataxia

March 1, 2023

The FDA has approved Skyclarys™ (omavaeloxolone) for the treatment of Friedreich ataxia in patients 16 years of age and older.

United States Reata Pharmaceuticals Drug Administration Friedreich Ataxia Research Alliance Ataxia Rating Scale Priority Review

Source: empr.com

Biogen Inc.: Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

February 28, 2023

TOKYO and CAMBRIDGE, Mass., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts

United Kingdom United States Dennis Riedl Haruo Naito Christophera Viehbacher Mike Hencke

Source: finanznachrichten.de

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

February 28, 2023

28.02.2023 - TOKYO and CAMBRIDGE, Mass., Feb. 27, 2023 (GLOBE NEWSWIRE) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, Eisai) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, ... Seite 1

United Kingdom United States Haruo Naito Christophera Viehbacher Eisai Co Ltd National Medical Products Administration

Source: wallstreet-online.de

BIOLOGICS LICENSE APPLICATION FOR LECANEMAB DESIGNATED FOR PRIORITY REVIEW BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION

February 28, 2023

/PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,...

United Kingdom United States Haruo Naito Christophera Viehbacher Mike Hencke Natacha Gassenbach

Source: prnewswire.com

Eisai: Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

February 28, 2023

TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid

Dennis Riedl Natacha Gassenbach Ministry Of Health Drug Administration Biogen Inc Eisai Co Ltd

Source: finanznachrichten.de

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Biogen Says BLA For Lecanemab Gets Priority Review By NMPA In China

February 28, 2023

(RTTNews) - Eisai Co., Ltd. and Biogen Inc. (BIIB) Tuesday said the Biologics License Application (BLA) for lecanemab, has been designated for Pri...

Eisai Co Ltd European Medicines Agency National Medical Products Administration Biogen Inc Biologics License Application Priority Review

Source: businessinsider.com

BioArctic: Biologics License Application for lecanemab designated for Priority Review by China National Medical Products Administration

February 28, 2023

STOCKHOLM, Feb. 28, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Biologics License Application (BLA) for lecanemab (brand name

United States Uppsala Lan Dennis Riedl Oskar Bosson Uppsala University Vp Communications

Source: finanznachrichten.de

Nirogacestat Gets Priority Review for Treatment of Desmoid Tumors

February 28, 2023

The FDA has accepted for Priority Review the NDA for nirogacestat for the treatment of adult patients with desmoid tumors.

Saqib Islam Drug Administration Priority Review New Drug Application Prescription Drug User Fee Act Fast Track

Source: empr.com

Biologics License Application for lecanemab designated for Priority Review by China National Medical Products Administration

February 28, 2023

/PRNewswire/ -- BioArctic ABs (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Biologics License Application (BLA) for lecanemab...

United States Uppsala Lan Oskar Bosson Uppsala University Vp Communications National Institutes Of Health

Source: prnewswire.com