Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, ...

Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners. Manufacturing has ...

Investment firm Deerfield Management is the latest to find a gem in China, which has been rising as a source of biotech innovation over the past few years. Investment firm Deerfield Management has ...

With the failure in chronic spontaneous urticaria, Evommune’s story is now centered on its anti-IL-18 therapy EVO301, Oppenheimer said, which in February elicited a 33% placebo-adjusted improvement in ...

Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to ...

A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent ...

Jubilant HollisterStier received a warning letter over problems that the FDA said necessitate an immediate and comprehensive ...

The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told ...

After 27 deaths were reported in a group receiving its blood cancer drug, ADC Therapeutics is downsizing, implementing ...

Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy ...

Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was ...

Following the mid-stage readout, Verastem Oncology has decided to move away from its investigational pancreatic cancer drug ...