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 ...

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 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 ...

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

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

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 ...

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 ...

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 ...

Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how ...

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 ...

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