Industry Dynamics

Industry News

03-14

2024

Wegovy® approved in the US for cardiovascular risk reduction in people with overweight or obesity and established cardiovascular disease

March 8, 2024 -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy® based on a supplemental New Drug Application (sNDA) for the indication of reducing r……

02-29

2024

Everest Medicines and Kezar Life Sciences Receive IND Approval from China NMPA for PALIZADE Trial in Lupus Nephritis

February 27, 2024-Everest Medicines announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for ini……

02-19

2024

FDA Approves First Medication to Treat Severe Frostbite

February 24, 2024 -- The U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.“This approval provides patients with t……

01-26

2024

FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

January 29, 2024 -- the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alter……

01-10

2024

Phase 3a trial for combination of basal insulin icodec and semaglutide was successfully completed

January 8, 2024-Novo Nordisk today announced topline results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. COMBINE 3 was a 52-week, open……

12-28

2023

Calliditas Therapeutics announces full FDA approval of TARPEYO®, the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function

December 20, 2023 -- Calliditas Therapeutics AB, today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults……

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