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 ...

After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the ...

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 ...

Antonio Serrano, PhD, MBA, is founder of Bioicus Lab, currently based at Harwell Science and Innovation Campus in Oxfordshire ...

The 2022 search approach is no longer working. Companies need to think critically about how they are acquiring top regulatory ...

The centerpiece of the acquisition is Myricx Bio’s novel N-myristoyltransferase inhibitor payload platform, which could help Novartis develop antibody-drug conjugates that can overcome the limitations ...

Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has ...

With the latest round, Roche’s Genentech will have racked up nearly 450 layoffs in California over the last year amid ongoing restructuring. At the same time, the biotech is joining forces with Astex ...

Scribe Therapeutics’ pipeline is immature, with its lead program recently greenlit for first-in-human testing. The biotech is working on CRISPR-based therapies for cardiometabolic diseases. Scribe ...

Bispecific antibodies represent a rapidly expanding class of biotherapeutics, presenting distinct innovation trends across ...

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 ...