Astellas' first-in-class CLDN18.2 drug Vyloy has cleared the FDA. After a positive phase 3 readout, Otsuka is targeting an ...

The regulator’s approval on Friday of Vyloy for gastric or gastroesophageal junction cancer makes it the first and only ...

Vyloy is the first CLDN18.2-targeting drug to reach the US market but has already been approved in Japan as well as in the EU ...

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer ...

The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...

The US Food and Drug Administration has approved Vyloy (zolbetuximab-clzb), a claudin 18.2 (CLDN18.2)-directed cytolytic ...

Astellas Pharma has gained approval from the US Food and Drug Administration (FDA) for VYLOY (zolbetuximab-clzb), in ...

Astellas Pharma today announced that the US Food and Drug Administration (FDA) has approved VYLOY (zolbetuximab-clzb) in ...

Astellas Pharma Inc. (OTCMKTS:ALPMY – Get Free Report) was the target of a large growth in short interest during the month of ...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) in combination ...

Astellas Pharma Ltd. today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization for PADCEV™ (enfortumab vedotin, an antibody-drug conjugate [ADC]) in ...

VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive TOKYO, Oct. 18 ...