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Ligand Pharmaceuticals, Inc.

http://www.ligand.com

Latest From Ligand Pharmaceuticals, Inc.

Agenus Needs Phase III For BOT/BAL, Another Example Of Shifting Accelerated Approval Climate

The US FDA surprised some observers when it advised Agenus against filing for accelerated approval of the CTLA-4/PD-1 combination, but the agency has been cracking down on confirmatory trial requirements recently to better ensure the studies will be finished.

Cancer Review Pathway

FDA Leaves Door Open For Further Discussions With Agenus Over BOT/BAL

The biotech company surprised observers when it announced the agency advised against filing for accelerated approval of the CTLA-4/PD-1 combination.

FDA Business Strategies

Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications

Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.

Rare Diseases Drug Approval Standards

Ligand Makes Second Big Oncology Investment In 2024 With Apeiron Buyout

The company is acquiring rights to royalties from Qarziba, a neuroblastoma drug approved in ex-US markets that Recordati develops and markets in all of them except mainland China.

Deals Cancer
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  • Biotechnology
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