Incyte Approval In Subset Of Cholangiocarcinoma May Lead To Bigger Opportunities

Biotech hopes this initial approval will be followed by approvals of Pemazyre in bladder cancer, first-line cholangiocarcinoma and possibly even a tumor-agnostic indication for FGFR-mutated cancers.

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Incyte got FDA's thumbs-up for Pemazyre in cholangiocarcinoma

Incyte Corp.’s US approval of Pemazyre (pemigatinib) for a genetic subset of the rare bile duct cancer cholangiocarcinoma is a small economic opportunity, but one that could eventually lead to a broader label for the target fibroblast growth factor receptor 2 (FGFR2) inhibitor.

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Pipeline Watch: Seventeen Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Sanofi Set To Shake Up Crowded Hemophilia Space After Qfitlia Approval

 
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The small interference RNA therapeutic can be used by patients regardless of inhibitor status.

Unicycive Approaches Its First Approval, But In A Competitive Space

 

The company is planning to launch oxylanthanum carbonate for chronic kidney disease patients on dialysis with hyperphosphatemia.

Soleno’s Vykat Gains First Prader-Willi Syndrome Approval, Rivals To Follow

 

After a long wait for patients, Vykat has become the first drug approved for Prader-Willi syndrome symptoms, opening the market up for Soleno and future challengers.

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Baxdrostat, AstraZeneca’s Next Big CVRM Bet

 
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The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.

Stock Watch: How Tariff Threat Might Boost Pharma Q1

 
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Supply chain disruption fears at the start of the COVID-19 pandemic caused drug over-ordering. Imminent tariffs on drugs may have had a similar effect on pharma sales in Q1 earnings season.

Merck’s Winrevair Slashes Morbidity-Mortality Risk For PAH Patients

 

The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.