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November 7, 2022
/PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today a progress update on its Biologics License Application (BLA) for valoctocogene...
October 17, 2022
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
October 3, 2022
As previously reported by Ark Valley Voice, the Salida City Council work session (normally scheduled for Mon. Oct. 3) moves to 5:00 p.m. Tues. Oct. 4 at
June 30, 2022
/PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated...
May 4, 2022
TARRYTOWN, N.Y., May 4, 2022 /PRNewswire/ --First quarter 2022 revenues increased 17% to $2.97 billion versus first quarter 2021; excluding REGEN-...
April 14, 2022
/PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended by three months...
March 15, 2022
The U.S. Food and Drug Administration extended the review period by three months for Incyte's (INCY) application seeking extended approval of ruxolitinib cream (Opzelura) to...
November 23, 2021
Amryt Provides Update on Regulatory Review Process for Oleogel-S10 FDA PDUFA goal date extended by three months to February 28, 2022 EMA CHMP opinion now expected in January 2022 DUBLIN, Ireland, and ...
January 29, 2021
Biogen Inc. Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021 CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Fo...
January 29, 2021
(2) The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021 CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimers disease. The updated Prescription Drug User Fee Act (PDUFA) action d...