Ten Approvals To Look Out For In Q4

From AstraZeneca’s benralizumab in asthma to Kite Pharma’s CAR-T therapy, Scrip takes a look at some of the more interesting drug approvals expected by the end of the year, with the help of analysts from Informa's Biomedtracker.

Pipes
Plenty of Approvals Coming through the pipeline • Source: Shutterstock

Catalyst: PDUFA for sNDA – First Review

Target action date: Nov. 6

Biomedtracker's LOA Opinion*: Above

*Biomedtracker’s proprietary rating of the likelihood of approval of a particular drug, in comparison to average approval rates for drugs in that class

As it is already approved for hyperphosphatemia, the chances for approval of the sNDA for Keryx Biopharmaceuticals Inc.'s Auryxia (ferric citrate) in iron-deficiency anemia appear hopeful, BMT analysts believe. Current oral iron formulations are over-the-counter and efficacy can be limited by side effects or compliance due to multiple doses, so the company is hoping that Auryxia could fill a needed gap in treatment.

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: Ten Approvals And Eleven 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.

2025’s Biggest Launches – Half-Year Progress Report

 

Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.

Dizal’s Zegfrovy Wins US NSCLC Approval, At Lower Dose Than In China

 

Dizal's EGFR inhibitor Zegfrovy approved in US as new once-daily oral option for second-line NSCLC with EGFR exon 20 insertion mutations, at lower dose than in China.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.

More from Scrip

In Brief: Concentra Snaps Up Struggling IGM Biosciences In Latest Biotech Deal

 

Concentra Biosciences is acquiring struggling IGM Biosciences for $1.25 per share plus a contingent value right, with the deal expected to close in August 2025.

Pipeline Watch: Ten Approvals And Eleven 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.

Quick Listen: Scrip’s Five Must-Know Things

 
• By 

In this week's episode: AbbVie’s big autoimmune CAR-T play; In Vivo CAR-T interest grows; China deal perspectives from BIO; global pharma interest in Korea undeterred; and a look at the biggest drug sales disappointments.