James Hackworth, PhD, is the chief business officer at Tris Pharma. With over 15 years of multi-therapeutic area experience domestically and internationally, he has an extensive track record in ...

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 ...

Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you. In June, average job postings live on the BioSpace website not only rose year ...

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 ...

The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this ...

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

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 ...

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

Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA. The FDA has selected seven companies to ...

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 ...

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