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

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

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 ...

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

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 ...

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 ...

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

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

Sarepta Therapeutics is seeking to convert the accelerated approval of its therapeutic exon-skippers for Duchenne muscular dystrophy to full despite the drugs’ failure to improve motor function in a ...

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 ...