Industry Dynamics

Industry News

03-27

2023

Pharming announces US FDA approval of Joenja® (leniolisib) as the first and only treatment indicated for APDS

March 24, 2023 -- Pharming Group N.V. (“Pharming” or “the Company”)(EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the US Food and Drug Administration (FDA) has approved Joenja® (leniolisib) for the treatment of ……

03-13

2023

OPKO Health’s ModeX Therapeutics Enters into Exclusive Worldwide License and Collaboration Agreement with Merck to Develop Epstein-Barr Virus Vaccine Candidate

MIAMI, March 08, 2023 – OPKO Health, Inc. (NASDAQ: OPK) today announced that ModeX Therapeutics, Inc., an OPKO Health company, entered into an exclusive worldwide license and collaboration agreement with Merck, known as ……

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……

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