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 ...

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

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

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

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 ...

GSK and Hansoh Pharmaceutical’s antibody-drug conjugate success validates their partnership, one of the many deals in which Big Pharma has tapped a China company for promising cancer candidates. GSK ...

Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the ...