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

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

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

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

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

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 ...

The approval of Ionis Pharmaceuticals’ Tryngolza for severe hypertriglyceridemia could spur “substantial growth” for the ...

Viridian Therapeutics’ Lumvoa is the first FDA-approved treatment for thyroid eye disease that includes data for both active and chronic forms of the illness. The FDA has signed off on Viridian ...

The star of Ipsen’s acquisition is an MDM2 blocker being proposed as an add-on therapy to ruxolitinib for myelofibrosis. The drug could be available to patients “as early as 2028,” according to Ipsen ...

The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition. After ...

For the 2026 fiscal year, Takeda anticipates declines in revenue and profit, highlighting what CEO-elect Julie Kim says is the need for the company to “invest in future growth.” Newly elected Takeda ...

The company is “especially excited” about an immune cell therapy manufacturing technology included in the deal, a Merck KGaA executive said. Merck KGaA has agreed to buy Bio-Techne for $11.3 billion ...