Terlivaz Approved By FDA As Mallinckrodt Seeks To Advance New Business Strategy

Terlivaz is the first product approved to improve kidney function in adults with hepatorenal syndrome (HRS). The approval is a milestone in a long regulatory road for the drug.

Keep trying
It took several attempts to get Terlivaz approved in the US • Source: Shutterstock

Mallinckrodt plc has a US drug launch to focus on as the company looks to implement a new business strategy under a new management team, after emerging from Chapter 11 bankruptcy proceedings earlier this year.

The US Food and Drug Administration approved Terlivaz (terlipressin), the first drug indicated to improve kidney function in adults with hepatorenal syndrome (HRS)

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Pipeline Watch: Eight Approvals And Nineteen 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.

In Brief: US FDA Delay Sends Biohaven Shares Down

 

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By 

As CEO Anderson backs high prices for innovative drugs in Europe

Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

 

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.

More from Scrip

Affimed’s ASCO ‘Hail Mary’ As Survival Chances Slim

 
• By 

The German biotech has been forced into insolvency and NASDAQ suspension.

Stock Watch: Bayer, Bavarian Nordic Bring European Cheer To Pharma

 
• By 

Investors welcomed Bavarian Nordic’s and Bayer’s earnings announcements. However, both stock prices declined over the day of their reports as the impact of recent pressures weighed.

In Brief: Essence Raises Ionis Tryngolza Hypertriglyceridemia Filing Hopes

 

Tryngolza has met endpoints in a moderate hypertriglyceridemia trial. Positive results in severe disease in Q3 could allow for a filing for a broader patient population than its currently approved indication of familial chylomicronemia syndrome.