A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible ...

The FDA also approved Thermo Fisher's Oncomine Dx Target Test as a companion diagnostic to identify patients eligible for Hyrnuo.

Regeneron announced the FDA’s approval of two indications of Eylea HD, including an 8mg injection for patients with macular ...

FDA grants accelerated approval to Bayer's Hyrnuo and full approval to Amgen's Imdelltra, expanding treatment options for ...

The accelerated FDA approval of Bayer's Hyrnuo covers treatment of advanced cases of non-small cell lung cancer with HER2 ...

U.S. FDA Approves HYRNUO® (sevabertinib) for Previously Treated Patients with HER2-Mutated Locally Advanced or Metastatic Non-Squamous NSCLC ...

Bayer (BAYRY) announced that the FDA has approved Hyrnuo, an oral, reversible, tyrosine kinase inhibitor for the treatment of adult patients with ...

FDA fast-tracks Bayer's Hyrnuo, unlocking a potential $800 million market and giving the stock another shot of life ...

The FDA has given accelerated approval to Bayer for oral HER2 tyrosine kinase inhibitor sevabertinib as a second-line treatment for advanced HER2-mutant non-small cell lung cancer (NSCLC), allowing it ...

BOSTON, Nov. 20, 2025 /PRNewswire/ -- TetraScience, the Scientific Data and AI Company, announced that Bayer AG will expand its deployment of TetraScience's Scientific Data Foundry across its ...

Bayer (BAYZF) stock is in focus as the FDA grants accelerated approval for the company's tumor drug Hyrnuo in non-squamous ...

The U.S. Food and Drug Administration said on Wednesday that it has approved Bayer's drug for patients with a form of lung ...