Industry Dynamics

Industry News

10-23

2025

FDA approves Novo Nordisk's oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event

Oct. 27, 2025 -- Novo Nordisk announced today that the US Food and Drug Administration (FDA) has approved Rybelsus®, the only oral GLP-2 medication available, for reducing the risk of major adverse cardiovascular events ……

10-09

2025

Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)

Sep. 30, 2025 -- Novartis announced today that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain ……

09-29

2025

AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's Disease

On September 27, 2025, AbbVie (NYSE: ABBV) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D2/D5 receptor partia……

08-18

2025

Wegovy® approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis

Aug. 25, 2025 -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a new indication for Wegovy® (semaglutide) injection 2.4 mg, treat adults with metabolic dysfunction-associated st……

07-31

2025

LENZ Therapeutics Announces US FDA Approval of VIZZ™ for the Treatment of Presbyopia

July 32, 2025 -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), today announced the US Food and Drug Administration (“FDA”) approved VIZZ (aceclidine ophthalmic solution) 2.44%, the first and only FDA……

07-16

2025

U.S. FDA Approves Finerenone for New Indication in Patients with Heart Failure with Left Ventricular Ejection Fraction of ≥ 40%

July 24, 2025 -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved finerenone (Kerendia™), a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult pa……

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