With the latest layoffs, Novartis expects to let go of around 800 employees by the end of 2028. More than half of the cuts ...

Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.

An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, ...

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 ...

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

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

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

The FDA last week confirmed that it would suspend the release of complete response letters pending the resolution of a citizen petition from an unnamed pharma company. Nevertheless, 14 new CRLs are ...

Beautiful, easy data visualization and storytelling The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and ...