Approval News - Candlesense

Madrigal Receives European Commission Approval for Rezdiffra™ (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis

CONSHOHOCKEN, Pa., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-...

How does Rezdiffra's market positioning compare to existing and pipeline MASH therapies in terms of competitive advantage and market share potential? What pricing and reimbursement strategy will Madrigal pursue in Europe, and how might that impact profit margins? How will the EU approval of Rezdiffra affect Madrigal's revenue forecasts and valuation?

Symbol: MDGL

1 day ago

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Iovance’s Amtagvi® (lifileucel) Receives Health Canada Approval for Advanced Melanoma

First T cell therapy for a solid tumor cancer and first treatment option approved in Canada for advanced melanoma after anti-PD-1 and targeted therapy

How does this approval position Iovance against competitors in the T‑cell and melanoma space, and what are the implications for its broader pipeline and future regulatory milestones? What is the expected commercial launch timeline in Canada, including pricing, reimbursement and market uptake compared to existing melanoma therapies? How will the Health Canada approval of Amtagvi® affect IOV's short‑term and near‑term stock price and trading volume?

Symbol: IOV

2 days ago

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Novo Nordisk A/S: Wegovy® approved in the US for the treatment of MASH

Bagsværd, Denmark, 15 August 2025 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved an additional indication for Wegovy® (semaglutide 2.4 mg) based on a sup...

Are there any anticipated partnerships or collaborations to support MASH market penetration that could affect Novo's strategic outlook? How might this news impact short‑term trading volume and volatility of NVO stock? What regulatory or safety considerations remain for Wegovy in the MASH indication?

Symbol: NVO

5 days ago

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Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years

What is the anticipated impact on the company's debt and liquidity position? How will this approval affect the company's cash flow and ability to fund other pipeline programs? Does Tonix plan any additional indications or formulations for Tonmya in the future?

Symbol: TONX

5 days ago

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U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patients From the Start

ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacks Once-monthly dosing reduced HAE attacks by a median of more than 99 percent and ...

Symbol: CSL

2 months ago

U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, ...

Symbol: URGN

2 months ago

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U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, ...

Symbol: URGN

2 months ago

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Enanta Pharmaceuticals’ Partner AbbVie Receives U.S. FDA Approval of an Expanded Indication for MAVYRET® (glecaprevir/pibrentasvir) as the First and Only Treatment for People with Acute Hepatitis C Virus

WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunologic...

Symbol: ENTA

2 months ago

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Ouster Digital Lidar Approved by Defense Department for Unmanned Aircraft

SAN FRANCISCO--(BUSINESS WIRE)---- $OUST--Ouster, Inc. (Nasdaq: OUST) (“Ouster” or the “Company”), a global leader in high-performance lidar sensors and intelligent software solutions, powering Phy...

Symbol: OUST

2 months ago

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