Industry Dynamics

Industry News

02-03

2023

FDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis

February 02, 2023 -- Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for……

01-31

2023

Stemline Therapeutics, a Subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDU™ (elacestrant)

January 30, 2023 -- Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, announced today that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmeno……

01-09

2023

FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment

January 06, 2023 -- Today, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category of……

11-10

2022

U.S. Food and Drug Administration Approves Vemlidy® (tenofovir alafenamide) for Treatment of Chronic Hepatitis B Virus Infection in Pediatric Patients

November 02, 2022--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 m……

10-28

2022

AbbVie Acquires DJS Antibodies, Further Strengthening Immunology Pipeline

Oct. 20, 2022, AbbVie (NYSE: ABBV) today announced the acquisition of DJS Antibodies Ltd ("DJS"), Under the terms of the agreement, AbbVie will pay DJS shareholders approximately $255 million in cash at cl……

10-18

2022

Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen

Oct. 27, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for tofersen by three months.……

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