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Intercept Unlikely To Refile OCA For NASH Before Late 2021

 
• By Joseph Haas

Once determined to resubmit its NDA by the end of 2020, Intercept now says talks with the FDA have presented a new path to approval in non-alcoholic steatohepatitis that could mean refiling sometime in 2021.

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Intercept can see a path forward in NASH, but it will take a while

Intercept Pharmaceuticals, Inc.’s announcement that it hopes to refile the new drug application for obeticholic acid, its non-alcoholic steatohepatitis drug candidate, sometime in 2021 dramatically changes the timeline for the drug’s potential approval, but investors responded positively to the news, perhaps indicating relief that a clear path to approval now seems to be in place.

During the company’s third quarter earnings call on 9 November, CEO Mark Pruzanski said a type A end-of-review meeting with...

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Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

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UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 
• By Jessica Merrill

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

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ASCO: Pushing The Frontiers Of ADCs

 
• By Mary Jo Laffler

Antibody-drug conjugates are a major part of the oncology pipeline, and data presented at the American Society of Clinical Oncology meeting highlight the emergence of new technologies.

Top 10 Drugs Q1 2025: Keytruda Dominates; Mounjaro Climbs

 
• By Eleanor Malone

Lilly’s Mounjaro for diabetes rose from sixth to third position among the top-selling drugs in the first quarter of 2025, Rival Ozempic retained second position and Merck & Co’s immuno-oncology blockbuster Keytruda stayed far ahead.

Skyhawk Looks To Soar With Huntington’s Hope

 
• By Kevin Grogan

Oral RNA splicing modulator has gone into a Phase II/III trial