The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Zai Lab’s delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), ZL-1310, for small cell lung cancer (SCLC).

The goal is to treat familial dysautonomia patients with a single injection.

On Thursday, 2119 stocks advanced, 1842 declined and 106 remained unchanged, with an advance decline ratio of 1.15 on the ...

Regulatory authorities, particularly the US Food and Drug Administration (FDA), have played a crucial role in accelerating and incentivizing the development of innovative treatments through review ...

The NPI-001 (N-acetylcysteine amide) tablets are a proprietary investigational therapy for the treatment of patients with ...

Zai Lab Limited (ZLAB) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation or ODD to ZL-1310, a ...

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class ...

Insilico Medcine( "Insilico") , a clinical stage generative artificial intelligence (AI)-driven biotechnology company today announced the first patient has been dosed in the global multicenter Phase I ...

Nuvalent, Inc. shares have fallen approximately 30% after promising updates on its two lead NSCLC candidates rallied the ...

Breakthrough therapy designation recognises the potential of brelovitug to transform the lives of people living with CHD. We ...

The FDA has granted fast-track designation to an investigational antisense oligonucleotide to treat individuals with myotonic ...

Zydus Lifesciences announced that Usnoflast, a treatment for amyotrophic lateral sclerosis (ALS), has received Orphan Drug Designation from the US FDA. This designation supports the development of ...