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Industry Dynamics

Industry News

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……

06-27

2025

Sephience? (sepiapterin) Granted Marketing Authorization by the European Commission for the Treatment of Children and Adults Living with Phenylketonuria (PKU)

On June 24, 2025,  PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that Sephience? (sepiapterin) was granted marketing authorization by the European Commission for the treatment of children and adults living wi……

06-16

2025

U.S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI? (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer

On June 23, 2025, Nuvation Bio Inc. (NYSE: NUVB) announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI? (taletrectinib) for the treatment of adult patients with locally advanced or metastatic RO……

05-30

2025

Alcon’s Tryptyr Approved by FDA for Dry Eye Disease Treatment

May 28, 2025 -- Alcon announced that the FDA has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, for the treatment of the signs and symptoms of dry eye disease (DED). Tryptyr is a first - in - class TRPM8 recep……

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