After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up ...

In its second attempt, Takeda has secured FDA approval for Eohilia, which becomes the first and only oral therapy in the US for eosinophilic oesophagitis (EoE). The US regulator has cleared ...

Credit: Emily frost/Shutterstock.com. Astellas Pharma has gained approval from the US Food and Drug Administration (FDA) for VYLOY (zolbetuximab-clzb), in conjunction with chemotherapy, for the ...

Roche (ROG.S), opens new tab said on Friday that the FDA had approved its companion diagnostic test to identify patients who may be eligible for Vyloy. The FDA had previously declined to approve ...

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at ...

On Thursday, the FDA approved AbbVie Inc’s (NYSE:ABBV) Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for motor fluctuations ...

Until recently, physicians who wanted to map PFA procedures had to use systems from third parties, primarily Abbott and J&J. That has changed in the past week, with the Affera authorization coming ...

Oct. 18, 2024 -- The FDA has approved a new injectable treatment for adults with advanced Parkinson’s disease called Vyalev (also known as Produodopa). This new option is designed to help people ...

Sulopenem, which will now go by the commercial moniker Orlynvah, was approved by the FDA Friday to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli, Klebsiella pneumoniae or ...

Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA approved oral sulopenem etzadroxil and probenecid (Orlynvah) to treat uncomplicated urinary tract infections ...