An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.” The FDA ...

The late-stage miss is “surprising,” Stifel analysts said, given that Wainua’s mechanism of silencing transthyretin protein expression has previously proven effective. AstraZeneca and Ionis ...

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

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 ...

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 ...

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

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 FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told ...

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

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

After being bought by Bain for $3.3 billion, Tanabe has reached a deal to sell its manufacturing unit and 17 products. Tanabe Pharma has struck a deal to sell its Japanese manufacturing plants to Towa ...