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

The mid-stage disappointment in Alzheimer’s disease delivers another blow to Neuphoria Therapeutics, which in November last year was forced to launch a strategic business review after a Phase 3 trial ...

Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright ...

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

The FDA approved the expansion of Casgevy, which had previously been greenlit for patients 12 and up, into a younger pediatric population under the agency’s Commissioner’s National Priority Voucher ...

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

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

Vijay Kumar, acting director of CBER’s Office of Therapeutic Products, will leave his role at a tumultuous time for the FDA. The FDA’s acting director in charge of cell and gene therapy, Vijay Kumar, ...

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

The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back. Nine deals from Eli Lilly. Three ...

Innovation drives CROs to win new business, but unchecked customization creates complexity that undermines reproducibility, weakens renewals and leads to turnover—making standardization a strategic ...